Case 3:21-cv-00105-BEN-KSC Document 1 Filed 01/20/21 PageID.1 Page 1 of 94
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`
`Andrew N. Thomases (SBN 177339)
`andrew.thomases@ropesgray.com
`James F. Mack (SBN 322056)
`james.mack@ropesgray.com
`David A. Serati (SBN 329811)
`david.serati@ropesgray.com
`ROPES & GRAY LLP
`1900 University Avenue
`6th Floor
`East Palo Alto, CA 94303
`Telephone: (650) 617-4000
`Counsel for Plaintiffs
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF CALIFORNIA
`
`XpandOrtho, Inc.;
`Case No.
`Exactech, Inc.
`
`Plaintiffs,
`COMPLAINT
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`1. Violation Of Defend Trade
`v.
`Secrets Act
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`2. Aiding And Abetting Violation
`Zimmer Biomet Holdings, Inc.;
`Of Defend Trade Secrets Act
`Zimmer, Inc.;
`3. Violation Of California Uniform
`Zimmer US, Inc. d/b/a Zimmer
`Trade Secret Act
`Biomet Southern California;
`4. Aiding And Abetting Violation
`ORTHOsoft ULC d/b/a Zimmer CAS.
`Of California Uniform Trade
`Defendants.
`Secret Act
`
`5. Breach Of Contract
`6. Tortious Interference With
`Contract
`7. Breach Of The Implied
`Covenant Of Good Faith And
`Fair Dealing
`8. Fraud
`9. Conversion
`10. Unjust Enrichment
`11. Intentional Interference With
`Prospective Economic
`Advantage
`12. Negligent Interference With
`Prospective Economic
`Advantage
`13. Breach Of Confidence
`14. Copyright Infringement
`15. Violation Of Cal. Bus & Prof.
`Code Section 17200
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`DEMAND FOR JURY TRIAL
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`COMPLAINT
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`CASE NO. ________________
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`'21
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`CV105
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`KSC
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`BEN
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`INTRODUCTION AND NATURE OF THE ACTION
`1.
`This civil action is brought by Plaintiffs XpandOrtho, Inc.
`(“XpandOrtho”) and Exactech, Inc. (“Exactech”) (collectively, “Plaintiffs”)
`against Defendants Zimmer Biomet Holdings, Inc., Zimmer, Inc., Zimmer US,
`Inc., and ORTHOsoft ULC (collectively, “Zimmer” or “Defendants”) in light of,
`inter alia, Defendants’ misappropriation of XpandOrtho’s property, including
`confidential, proprietary, and trade secret information, as well as Defendants’
`unfair competition, breach of contract, and infringement of certain of
`XpandOrtho’s registered copyrighted works.
`2.
`In 2012, two orthopedic surgeons associated with Scripps Health,
`Dr. Clifford Colwell and Dr. Darryl D’Lima, founded XpandOrtho to develop
`new technology to address the problem of inaccurate soft tissue balancing during
`total knee arthroplasty (also known as knee replacement). XpandOrtho was a
`small startup and sought to join forces with an established company to bring its
`technology to market.
`3.
`In 2018, Zimmer used the guise of a potential acquisition of
`XpandOrtho to convince XpandOrtho to provide extensive information about its
`technology and business. XpandOrtho ensured a Non-Disclosure Agreement
`(“NDA”) was in place to cover this transfer of information so that it could
`maintain the integrity of its confidential information, which was its major asset.
`Relying on this NDA and believing Zimmer was legitimately interested in an
`acquisition of XpandOrtho, XpandOrtho shared its design files, allowed Zimmer
`to test XpandOrtho’s proprietary devices at Zimmer’s labs, and allowed Zimmer
`to attend live clinical and cadaver surgeries in which XpandOrtho’s devices were
`used.
`
`4.
`After receiving all of this information, Zimmer stated that it was not
`interested in acquiring XpandOrtho. Zimmer then began misusing XpandOrtho’s
`proprietary information for its own benefit and in violation of the NDA. For
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`CASE NO. ________________
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`example, mere weeks calling off its purported potential acquisition, Zimmer
`secretly filed patent applications that incorporated XpandOrtho technology: U.S.
`Provisional Application Nos. 62/697,220 (attached as Exhibit 1 to this
`Complaint) and 62/697,227 (attached as Exhibit 2 to this Complaint) and
`corresponding publications U.S. Patent Application Publication Nos.
`2019/0240045 (attached as Exhibit 3 to this Complaint) and 2019/0240046
`(attached as Exhibit 4 to this Complaint). Zimmer used images of XpandOrtho’s
`XO1 product in their patent figures and even referenced XpandOrtho’s product
`by name—initially trying to cover up its misappropriation by redacting out
`XpandOrtho’s name. XpandOrtho did not consent to Zimmer’s use of
`XpandOrtho’s proprietary information in their patent applications and did not
`find out about the applications until after they were published, which publication
`occurred approximately a year after the applications were filed. Zimmer could
`not have developed the devices described in those applications without access to
`XpandOrtho’s proprietary
`information. Zimmer misused XpandOrtho’s
`proprietary information without consent in an effort to gain unfair competitive
`advantages, such as competing with XpandOrtho and improperly advancing
`Zimmer’s own R&D and patenting process.
`5.
`proprietary
`After Zimmer misappropriated XpandOrtho’s
`information, XpandOrtho entered into acquisition negotiations with Exactech. In
`March 2019, Exactech acquired XpandOrtho, and XpandOrtho is now a
`subsidiary of Exactech. At the time of acquisition, neither Exactech nor
`XpandOrtho was aware of Zimmer’s misappropriation, because Zimmer’s patent
`applications had not yet published. Exactech believed that it was acquiring a
`company with intellectual property assets that had not been misappropriated.
`Thus, both XpandOrtho and Exactech have been harmed by Zimmer’s wrongful
`conduct.
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`6.
`As described in more detail herein, in light of its improper actions,
`Zimmer should be found liable to XpandOrtho for its misappropriation of trade
`secrets, breach of contract, unfair competition, copyright infringement, and other
`wrongful acts, and subject to remedies including, but not limited to, payment of
`compensatory and punitive damages to XpandOrtho, payment of XpandOrtho’s
`attorney fees, assignment of its patent applications to XpandOrtho, and other
`legal and equitable remedies.
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`PARTIES
`7.
`XpandOrtho is a corporation duly organized under the laws of the
`State of Delaware. During the events detailed in this Complaint, and until its
`acquisition by Exactech, Inc. in 2019, XpandOrtho maintained its principal place
`of business at 2223 Avenida de la Playa, Suite 203, La Jolla, California 92037.
`XpandOrtho is now a wholly-owned subsidiary of Exactech. XpandOrtho now
`maintains its principal place of business at 2320 North West 66th Court,
`Gainesville, Florida 32653.
`8.
`XpandOrtho develops soft tissue balancing devices for use in joint
`replacement surgery, including the XO1 device.
`9.
`Exactech is a corporation duly organized under the laws of the State
`of Florida, and maintains its principal place of business at 2320 North West 66th
`Court, Gainesville, Florida 32653.
`10. Exactech makes joint replacement implants, instruments and
`technologies to serve surgeons and patients worldwide.
`11. On information and belief, Defendant Zimmer Biomet Holdings,
`Inc. is a Delaware corporation with its principal place of business located at 345
`East Main Street, Warsaw, Indiana 46580.
`12. On information and belief, Zimmer Biomet Holdings, Inc. regularly
`conducts business in the State of California and this District including as
`described herein.
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`CASE NO. ________________
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`13. On information and belief, Defendant Zimmer, Inc. is a Delaware
`corporation and is a subsidiary of Zimmer Biomet Holdings, Inc. On information
`and belief, Zimmer, Inc. maintains its principal place of business at 345 East
`Main Street, Warsaw, Indiana 46580.
`14. On information and belief, Zimmer, Inc. regularly conducts business
`in the State of California and this District including as described herein.
`15. On information and belief, Defendant Zimmer US, Inc. is a
`Delaware corporation and is a subsidiary of Zimmer Biomet Holdings, Inc. On
`information and belief, Zimmer US, Inc. maintains its principal place of business
`at 1800 West Center Street, Warsaw, Indiana 46581.
`16. On information and belief, Zimmer US, Inc. does business as
`Zimmer Biomet Southern California.
`17. On information and belief, Zimmer US, Inc. regularly conducts
`business in the State of California and this District including as described herein.
`18. On information and belief, Defendant ORTHOsoft ULC d/b/a
`Zimmer CAS is a Canadian corporation and is a subsidiary of Zimmer Biomet
`Holdings, Inc. ORTHOsoft ULC maintains its principal place of business at 75
`Queen Street, Suite 3300, Montreal, Quebec, Canada H3C 2N6.
`19. On information and belief, ORTHOsoft ULC regularly conducts
`business in the State of California and this District including as described herein.
`20. On information and belief, Zimmer Biomet Holdings, Inc., Zimmer,
`Inc., Zimmer US, Inc., and ORTHOsoft ULC are, and were during all times
`relevant to this Complaint, alter egos of and agents of each other.
`21. On information and belief, all subsidiaries of Zimmer Biomet
`Holdings, Inc., including Zimmer, Inc., Zimmer US, Inc., and ORTHOsoft ULC
`are, and were during all times relevant to this Complaint, directed and controlled
`by Zimmer Biomet Holdings, Inc.
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`CASE NO. ________________
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`JURISDICTION AND VENUE
`22.
`Jurisdiction is based on 28 U.S.C. §§ 1331 and 1338, 18 U.S.C.
`§ 1836(c), Plaintiffs’ claims under 18 U.S.C. §§ 1836-39, et seq., for
`misappropriation of trade secrets under the Defend Trade Secrets Act, and
`Plaintiffs’ claims under 17 U.S.C. § 501 et seq. for copyright infringement.
`23. This Court has supplemental jurisdiction pursuant to 28 U.S.C
`§ 1367 over all other claims that do not arise under the Constitution, laws, or
`treaties of the United States because they involve a common nucleus of operative
`fact.
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`24. This Court has personal jurisdiction over Defendants because the
`Defendants have engaged in acts or omissions within this State causing injury,
`have engaged in acts or omissions outside of this State causing injury within this
`State, and/or otherwise has made or established the requisite minimum contacts
`within this State sufficient to permit the exercise of personal jurisdiction,
`including but not limited to physical visits to XpandOrtho’s facilities and
`suppliers in this District to obtain access to the XpandOrtho proprietary
`information discussed herein, e-mail sent to XpandOrtho employees based in this
`District, phone calls with XpandOrtho employees in this District, and numerous
`other contacts and communications in and into California over the span of many
`years in furtherance of the acts giving rise to this litigation, as well as the
`intentional misappropriation of intellectual property belonging to a California-
`based company.
`25. Upon information and belief, Zimmer Biomet Holdings, Inc.’s
`California locations include a location at 1900 Aston Ave., Carlsbad, CA 92008.
`Zimmer Biomet Holdings, Inc. employs people within this District, provides
`services within the District, conducts business and enters into agreements within
`this District, and its actions caused injury to XpandOrtho within this District.
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`CASE NO. ________________
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`26. Zimmer Biomet Holdings, Inc. has subsidiaries incorporated in
`California and doing business in California, including Interpore Cross
`International, LLC dba Zimmer Biomet Irvine and Synvasive Technology, Inc.,
`27. On information and belief, Zimmer Biomet Holdings, Inc. has one
`or more subsidiaries doing business in California.
`28. On information and belief, Zimmer US, Inc. is a subsidiary of
`Zimmer Biomet Holdings, Inc. and does business in California and in this District
`as Zimmer Biomet Southern California.
`29. Particularly, on information and belief, Zimmer Biomet Holdings,
`Inc. employees, consultants, or persons otherwise associated with Zimmer
`Biomet Holdings, Inc. or its subsidiaries traveled to California and this District
`in connection with the acts complained of herein, including: the 2015 meeting
`with Zimmer Pacific in La Jolla; the 2016 visit to La Jolla by Zimmer Biomet
`Holdings CEO David Dvorak; the May 23-25, 2018 visit to XpandOrtho’s
`facilities and suppliers in Solana Beach, Carlsbad, and Santa Fe Springs; the May
`31, 2018 visit to XpandOrtho’s facilities in Solana Beach; and the June 15, 2018
`observation of the clinical trial at Scripps Green Hospital in La Jolla.
`30. Zimmer Biomet Holdings, Inc. employees, consultants, or persons
`otherwise associated with Zimmer Biomet Holdings or one of its subsidiaries
`have sent e-mail to XpandOrtho personnel in this District, and participated in
`phone calls with XpandOrtho employees in this District in furtherance of the acts
`giving rise to this litigation. Upon information and belief, Zimmer Biomet
`Holdings, Inc. employees, consultants, or persons otherwise associated with
`Zimmer Biomet Holdings or one of
`its subsidiaries misappropriated
`XpandOrtho’s confidential and proprietary information that was developed in
`this District, and converted the same for the benefit of themselves and Zimmer
`Biomet Holdings, Inc.
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`CASE NO. ________________
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`31. Upon information and belief, Zimmer, Inc. employs people within
`this District, provides services within the District, conducts business and enters
`into agreements within this District, and its actions caused injury to XpandOrtho
`within this District.
`32. Particularly, Zimmer, Inc. entered into multiple contracts with
`XpandOrtho, a company based in this District, including the following contracts:
`(a) an NDA on March 4, 2015 (“2015 NDA”); (b) an amendment to the 2015
`NDA on May 8, 2018 (“2018 Amendment”), and (c) a Letter of Intent (“LOI”)
`on May 7, 2018.
`33. On information and belief, Zimmer, Inc. employees, consultants, or
`persons otherwise associated with Zimmer, Inc. or a related entity traveled to this
`District in connection with the acts complained of herein, including: the 2015
`meeting with Zimmer Pacific in La Jolla; the 2016 visit to La Jolla by Zimmer
`Biomet Holdings CEO David Dvorak; the May 23-25, 2018 visit to
`XpandOrtho’s facilities and suppliers in Solana Beach, Carlsbad, and Santa Fe
`Springs; the May 31, 2018 visit to XpandOrtho’s facilities in Solana Beach; and
`the June 15, 2018 observation of the clinical trial at Scripps Green Hospital in La
`Jolla.
`
`34. Zimmer, Inc. employees, consultants, or persons otherwise
`associated with Zimmer, Inc. or a related entity have sent e-mail to XpandOrtho
`personnel in this District, and participated in phone calls with XpandOrtho
`employees in this District in furtherance of the acts giving rise to this litigation.
`Upon information and belief, Zimmer, Inc. employees, consultants, or persons
`otherwise associated with Zimmer, Inc. or a related entity misappropriated
`XpandOrtho’s confidential and proprietary information that was developed in
`this District, and converted the same for the benefit of themselves and Zimmer,
`Inc.
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`35. Zimmer, Inc. has registered with the California Secretary of State to
`do business in California as Zimmer Biomet Corporate Services and has
`designated as an agent for service of process in California the “Corporation
`Service Company Which Will Do Business In California As CSC - Lawyers
`Incorporating Service” at 2710 Gateway Oaks Drive, Suite 150N, Sacramento,
`CA 95833.
`36. Upon information and belief, Zimmer US, Inc. employs people
`within this District, provides services within the District, conducts business and
`enters into agreements within this District, and its actions caused injury to
`XpandOrtho within this District.
`37. On information and belief, Zimmer US, Inc. employees, consultants,
`or persons otherwise associated with Zimmer US, Inc. or a related entity traveled
`to this District in connection with the acts complained of herein, including: the
`2015 meeting with Zimmer Pacific in La Jolla; the 2016 visit to La Jolla by
`Zimmer Biomet Holdings CEO David Dvorak; the May 23-25, 2018 visit to
`XpandOrtho’s facilities and suppliers in Solana Beach, Carlsbad, and Santa Fe
`Springs; the May 31, 2018 visit to XpandOrtho’s facilities in Solana Beach; and
`the June 15, 2018 observation of the clinical trial at Scripps Green Hospital in La
`Jolla.
`
`38. Zimmer US, Inc. employees, consultants, or persons otherwise
`associated with Zimmer US, Inc. or a related entity have sent e-mail to
`XpandOrtho personnel in this District, and participated in phone calls with
`XpandOrtho employees in this District in furtherance of the acts giving rise to
`this litigation. Upon information and belief, Zimmer US, Inc. employees,
`consultants, or persons otherwise associated with Zimmer US, Inc. or a related
`entity misappropriated XpandOrtho’s confidential and proprietary information
`that was developed in this District, and converted the same for the benefit of
`themselves and Zimmer US, Inc.
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`39. Zimmer US, Inc. has its principal executive office, chief executive
`officer, secretary, and chief financial officer at 11501 Dublin Blvd., Dublin,
`California 94568. Zimmer US, Inc. has registered with the California Secretary
`of State to do business in California and has designated Peter Katz as an agent
`for service of process in California at 11501 Dublin Blvd., Dublin, California
`94568.
`40. Upon information and belief, ORTHOsoft ULC conducts business
`and enters into agreements within this District, and its actions caused injury to
`XpandOrtho within this District.
`41. Particularly, ORTHOsoft ULC employees, consultants, or persons
`otherwise associated with ORTHOsoft ULC or a related entity traveled to this
`District in connection with the acts complained of herein, including: the 2015
`meeting with Zimmer Pacific in La Jolla; the 2016 visit to La Jolla by Zimmer
`Biomet Holdings CEO David Dvorak; the May 23-25, 2018 visit to
`XpandOrtho’s facilities and suppliers in Solana Beach, Carlsbad, and Santa Fe
`Springs; the May 31, 2018 visit to XpandOrtho’s facilities in Solana Beach; and
`the June 15, 2018 observation of the clinical trial at Scripps Green Hospital in La
`Jolla.
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`42. ORTHOsoft ULC employees, consultants, or persons otherwise
`associated with ORTHOsoft ULC or a related entity have sent e-mail to
`XpandOrtho personnel in this District, and participated in phone calls with
`XpandOrtho employees in this District in furtherance of the acts giving rise to
`this litigation. Upon information and belief, ORTHOsoft ULC employees,
`consultants, or persons otherwise associated with ORTHOsoft ULC or a related
`entity misappropriated XpandOrtho’s confidential and proprietary information
`that was developed in this District, and converted the same for the benefit of
`themselves and ORTHOsoft ULC.
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`43. ORTHOsoft ULC is the assignee of record at the U.S. Patent &
`Trademark Office of U.S. Patent Application Nos. 16/262,465 and 16/262,482,
`which are the fruits of the wrongful acts complained of herein.
`44. Venue is proper within this district because a substantial part of the
`events or omissions giving rise to the claims alleged in this Complaint occurred
`in this District, XpandOrtho maintained its principal place of business in this
`District during all relevant events detailed in this Complaint, and XpandOrtho’s
`founders Dr. Colwell and Dr. D’Lima are residents of California and residents of
`this District. In addition, XpandOrtho and Zimmer, Inc. consented in writing that
`California law shall govern the nondisclosure agreement under which the
`confidential disclosures detailed in this Complaint were made. Venue is therefore
`proper in the United States District Court for the Southern District of California
`pursuant to 28 U.S.C. § 1391(b)(1) and (2).
`FACTUAL ALLEGATIONS
`XpandOrtho And Its Products And Services
`45. Dr. Colwell and Dr. D’Lima are renowned orthopaedic surgeons and
`researchers at Scripps. In 2012, they founded XpandOrtho to solve the problem
`of inaccurate ligament balancing during total knee arthroplasty.
`46. Dr. Colwell has 40 years of surgical expertise in joint arthroplasty
`and arthroscopy. Dr. Colwell has been associated with Scripps since 1970 and is
`Medical Director of the Shiley Center for Orthopaedic Research and Education
`at Scripps Clinic, a Clinical Member of Scripps Clinic, Adjunct Clinical
`Professor at The Scripps Research Institute, all in La Jolla, California, Clinical
`Professor at the University of California, San Diego School of Medicine in San
`Diego, California, and Director of the Alfred A. and Marian E. Smith Joint
`Mechanics Laboratory, a combined effort of Scripps Clinic, Children’s Hospital
`and Health Center; the University of California, San Diego; San Diego State
`University; and the University of San Diego. Dr. Colwell was the team physician
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`of the San Diego Padres from 1980-2005 and of the America3 team in the 1994-
`1995 America’s Cup.
`47. Dr. D’Lima has been an orthopaedic surgeon and researcher for over
`twenty years. Dr. D’Lima has been associated with Scripps since 1994 and is
`Professor of Molecular Medicine at The Scripps Research Institute, Director of
`Orthopaedic Research at Scripps Health, Associate Professor in the Scripps
`Translational Science Institute at Scripps Health, and the Clifford W. Colwell Jr.,
`M.D. Chair in Orthopaedic Research at the Shiley Center for Orthopaedic
`Research and Education at Scripps Clinic, all in La Jolla, California.
`48. From 2012 until 2019, XpandOrtho was a small startup run by Dr.
`Colwell and Dr. D’Lima to develop soft tissue balancing products. XpandOrtho
`never had employees. Dr. Colwell was a consultant to XpandOrtho and also
`served as President, Chief Financial Officer, Secretary, and Chairman of the
`Board. Dr. D’Lima was a consultant to XpandOrtho and also served as Chief
`Scientific Officer, Vice President, and member of the Board.
`49. XpandOrtho sought to be acquired by a larger company, or to
`otherwise partner with a larger company with the resources to bring
`XpandOrtho’s technology to market.
`In 2015, XpandOrtho began discussions with Zimmer regarding a potential
`acquisition. These discussions continued through 2018, when the parties entered
`into a Letter of Intent and underwent an exhaustive due diligence process. After
`receiving XpandOrtho’s confidential information and trade secrets, Zimmer
`terminated the due diligence and declined to acquire XpandOrtho.
`50.
`In 2019, Exactech acquired XpandOrtho. XpandOrtho is now a
`wholly-owned subsidiary of Exactech. Exactech seeks to further develop and
`bring to market XpandOrtho’s technology.
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`Case 3:21-cv-00105-BEN-KSC Document 1 Filed 01/20/21 PageID.13 Page 13 of 94
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`II. Background of Knee Balancing Technology
`A. Ligament Balancing in Knee Arthroplasty
`51. At the time XpandOrtho was founded, total knee arthroplasty (knee
`replacement surgery) was successful in relieving pain due to arthritis of the knee
`joint, but patients were often dissatisfied due to residual pain and reduced range
`of motion. One of the primary causes of the need for additional corrective surgery
`in the short term was ligament instability caused by incorrect balancing of
`ligament tensions during arthroplasty. Ligament balancing remains an art and is
`largely dependent on the surgeon’s intuition and subjective “feel.”
`52. During knee arthroplasty, a surgeon balances the soft tissue
`(ligaments and tendons) to ensure that the knee moves properly with the
`permanent implant in place. The knee has four major ligaments: the anterior
`cruciate ligament (ACL), the posterior cruciate ligament (PCL), the medial
`collateral ligament (MCL), and the lateral collateral ligament (LCL). These
`ligaments are generally in tension, both in healthy knees and after surgery. In
`total knee arthroplasty (TKA), the ACL is often removed entirely, and
`approximately half of surgeons also remove the PCL. Thus, balancing the MCL
`and LCL (and the PCL, if retained) is often the surgeon’s focus during TKA. If
`the ligaments have improper tension, or if one ligament is tighter than the other,
`then the knee is said to be imbalanced. This imbalance often manifests in the gap
`between the tibia and femur (the tibiofemoral gap). For example, if the MCL is
`too tight, then the medial side of the tibiofemoral gap will be smaller than the
`lateral side. This side-to-side difference is referred to as “tilt.” The gap can also
`increase or decrease, or tilt, as the knee moves from full flexion to full extension.
`Conventional wisdom favors rectangular gaps (i.e., the same gap on the medial
`and lateral sides of the knee) that are equal in flexion and extension. Some in the
`field define a well-balanced knee as having the tibia and femur aligned with each
`other, a symmetric mediolateral balance in flexion and extension (i.e. equal
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`Case 3:21-cv-00105-BEN-KSC Document 1 Filed 01/20/21 PageID.14 Page 14 of 94
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`tension in the MCL and LCL), and an equal flexion−extension gap. While these
`criteria seem intuitive, quantifiable evidence linked to clinical outcomes has yet
`to be provided.
`53. The surgeon can affect ligament balance in three primary ways.
`First, the position and angle of the bone cuts made to the tibia and femur define
`the amount of room available for the implant components. Second, the surgeon
`can select implant components of different sizes and shapes, relative to the space
`available. Third, the surgeon can lower tension in a ligament by “releasing” the
`ligament. In ligament release, the surgeon removes some of the connective tissue
`attaching the ligament to the bone. The surgeon can also reduce the stiffness of
`the ligament by “pie-crusting” (making stab incisions in the body of the
`ligament). The surgeon can lengthen or tighten a ligament by cutting and sewing
`to change the length, or by moving the bony attachments. Occasionally the
`surgeon may cut or resect a ligament (e.g. the PCL) if it is too tight or cannot be
`released sufficiently.
`54. Primary knee replacements can require moderate to extensive
`ligament release. Ligament release generally improves outcomes in the short-
`term. On the other hand, extensive ligament releases have been linked to
`instability and abnormal knee kinematics.
`B.
`Existing Mechanical Balancing Instruments Were Inadequate
`55. At the time of XpandOrtho’s founding, several types of mechanical
`instruments were available to assist the surgeon in assessing soft tissue balance,
`but these instruments were inadequate. Spacer blocks and mechanical distractors
`are currently the most commonly used instruments and are often provided by the
`implant manufacturer. These devices are often inaccurate, and difficult to use to
`measure balance in midflexion, or without dislocating the patella.
`56. Spacer blocks of appropriate sizes are inserted into the knee and the
`laxity tested in flexion and extension. With joint distraction devices, the surgeon
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`manually exerts force on a distraction instrument to distract the joint and
`measures the gap between the bone cuts. The term “joint distraction” refers to
`separation of the bones in a joint. Mechanical instruments typically only measure
`the balance at the specific flexion angles of 0° and 90°, not throughout the full
`range of motion.
`57. Mechanical devices do not properly provide knee balance. Using
`mechanical devices, many knees can have significant mismatch
`in
`flexion−extension gaps despite the surgeon’s clinical impression that the knee is
`balanced. Even after manual balancing with mechanical devices, significant force
`imbalances between the medial and lateral compartments can exist, in some cases
`on the order of 50 lbs. Further, even with seemingly appropriate ligament release
`and intraoperative balancing, significant numbers of patients can experience
`condylar liftoff and abnormal tibial rotation.
`C. Existing Electronic Balancing Instruments Were Rudimentary
`58. At the time XpandOrtho was founded, some electronic balancing
`devices were commercially available, but were rudimentary. They were
`equivalent in concept to “spacer blocks” instrumented with force sensors.
`59. For example, Zimmer’s eLIBRA® device was used after making the
`tibial cut and the distal femoral bone cut, and specifies the rotational alignment
`of the posterior femoral cut to equalize forces in the medial and lateral
`compartments typically at a flexion angle of 90°. The eLibra device could only
`be used before the posterior femoral cut was made, and was not compatible with
`measured resection technique.
`60. As another example, Orthosensor’s VERASENSE® device
`measured forces in the medial and lateral compartments of the knee over the full
`range of flexion. This is based on the assumption that a balanced knee generates
`equal forces in flexion and extension, and equal forces in the medial and lateral
`compartments, but the assumption is difficult or impossible to measure. The
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`VERASENSE device was only compatible with a measured resection technique,
`since it required trial components mounted on bone cuts. Therefore, the
`VERASENSE device was not compatible with the balanced gap technique.
`61. Unfortunately, these devices did not transform ligament balancing
`from an art to a repeatable science. For example, even after seemingly appropriate
`soft-tissue releases and gap balancing, patients could still have residual
`differences in medial and lateral compartmental forces of greater than 75 lbs.
`III. XpandOrtho’s Soft Tissue Balancing Technology
`A. Overview of XpandOrtho’s Technology
`62. XpandOrtho designed the XO1 device to be a completely new
`electronic balancer that measures joint distraction over the full range of f