← Product Code [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH) · K073286 # GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM (K073286) _Zimmer, Inc. · JWH · Mar 7, 2008 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K073286 ## Device Facts - **Applicant:** Zimmer, Inc. - **Product Code:** [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH.md) - **Decision Date:** Mar 7, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3560 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use N-K Flex System: Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD). Components without CSTi porous coating are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. ## Device Story Gender Solutions Natural-Knee Flex System is a semiconstrained, nonlinked condylar knee prosthesis; designed for maximum active flexion of 155 degrees. Device components replace damaged knee joint surfaces to rehabilitate function in patients with degenerative or inflammatory joint disease. Used in surgical settings by orthopedic surgeons. Provides increased flexion capability for patients desiring greater range of motion. Substantial equivalence established via mechanical testing comparing subject device to predicate systems. ## Clinical Evidence No clinical data provided; substantial equivalence supported by non-clinical mechanical testing. ## Technological Characteristics Semiconstrained, nonlinked condylar knee prosthesis; includes options with and without CSTi porous coating. Materials include metal and polymer. Designed for maximum active flexion of 155 degrees. ## Regulatory Identification A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027). ## Predicate Devices - Gender Solutions Natural-Knee Flex System ([K070214](/device/K070214.md)) - Zimmer Patellofemoral Joint Prosthesis ([K070695](/device/K070695.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K073286 i/a ## Summary of Safety and Effectiveness # MAR - 7 2008 | Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 | |---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Brandon Hipsher, RAC
Associate Manager, Corporate Regulatory Affairs
Telephone: (574) 371-8083
Fax: (574) 372-4605 | | Date: | March 3, 2008 | | Trade Name: | Gender Solutions TM Natural-Knee ® Flex System | | Common Name: | Total Knee Prosthesis | | Classification Name
and Reference: | Knee joint patellofemorotibial
polymer/metal/polymer semiconstrained cemented
prosthesis
21 CFR § 888.3560
Knee joint patellofemorotibial metal/polymer
porous-coated uncemented prosthesis
21 CFR § 888.3565
Knee joint patellofemoral polymer/metal
semiconstrained cemented prosthesis
21 CFR § 888.3540 | | Predicate Devices: | Gender Solutions Natural-Knee Flex System,
manufactured by Zimmer, Inc., K070214, cleared
March 16, 2007.
Zimmer Patellofemoral Joint Prosthesis,
manufactured by Zimmer, Inc., K070695, cleared
June 7, 2007. | | Device Description: | The Gender Solutions Natural-Knee Flex (N-K
Flex) components are semiconstrained, nonlinked
condylar knee prosthesis that are designed to have a
maximum active flexion of 155 degrees. The N-K
Flex femoral provides increased flexion capability | {1}------------------------------------------------ ### K0739 86 2/2 for patients who have both the flexibility and desire to increase their flexion range. : : | Intended Use: | N-K Flex System:
Components with CSTi porous coating are
indicated for uncemented or cemented use in
skeletally mature individuals with intact medial
and lateral collateral ligaments undergoing
primary surgery for rehabilitating knees
damaged as a result of Noninflammatory
Degenerative Joint Disease (NIDJD) or
Inflammatory Joint Disease (IJD). Components without CSTi porous coating are
indicated for cemented use in skeletally mature
individuals with intact medial and lateral
collateral ligaments with conditions of
Noninflammatory Degenerative Joint Disease
(NIDJD) or Inflammatory Joint Disease (IJD),
correctable varus-valgus deformity and
moderate flexion contracture, or failed previous
surgery where pain, deformity or dysfunction
persists. | |----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Comparison to Predicate Device: | Except for dimensional and material modifications,
the subject components are identical to the predicate
device. | | Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions:
Mechanical testing of the subject devices
demonstrates that they are substantially equivalent
to the predicate devices.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for
these devices. | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is in black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Zimmer, Inc. % Mr. Brandon Hipsher P.O. Box 708 Warsaw, Indiana 46581-0708 MAR - 7 2008 Re: K073286 Trade/Device Name: Gender Solutions " Natural-Knee" Flex System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prothesis Regulatory Class: II Product Code: JWH, MBH, KRR Dated: March 3, 2008 Received: March 5, 2008 Dear Mr. Hipsher: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ #### Page 2 - Mr. Brandon Hipsher This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Mark N Millman Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### Indications for Use 510(k) Number (if known): K073286 Device Name: Gender Solutions™ Natural-Knee® Flex System #### Indications for Use: Gender Solutions" Natural-Knee® Flex System: - Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD). - · Components without CST are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (Please do not write below this line - Continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE) NishAr Ogl Ev mxn Page 1 of 1 Division of General, Restorative, and Neurological Devices 510(k) Number K073286 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K073286](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K073286) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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