(107 days)
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.
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 for patients who have both the flexibility and desire to increase their flexion range.
The provided text describes a 510(k) premarket notification for a medical device, the Gender Solutions™ Natural-Knee® Flex System. This is a type of knee replacement prosthesis. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than conducting a de novo study involving novel performance evaluation criteria for an AI/ML powered device.
Therefore, many of the requested categories related to AI/ML device performance and study design are not applicable to this submission.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
This submission is for a knee prosthesis, not an AI/ML powered diagnostic or prognostic device. As such, the "acceptance criteria" are not reported as specific performance metrics like sensitivity, specificity, or AUC, but rather the demonstration of substantial equivalence to existing, legally marketed predicate devices.
The primary "performance" assessed is mechanical equivalence to the predicate device.
| Acceptance Criterion (Implicit for 510(k)) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device in terms of safety and effectiveness | Mechanical testing demonstrates substantial equivalence to predicate devices. |
| Compliance with existing regulations for total knee prosthesis | Device meets the classification for knee joint prostheses (21 CFR § 888.3560, § 888.3565, § 888.3540). |
Study Details (Applicability to AI/ML Device Evaluation)
Given that this is a 510(k) submission for a traditional medical device (knee prosthesis), the following points related to AI/ML device evaluation are not applicable and are not discussed in the provided text:
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. The study involves mechanical testing of physical implants, not a "test set" of data for algorithm evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no concept of a "ground truth" derived from expert consensus in the context of mechanical testing for a knee prosthesis.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic or prognostic device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The ground truth for this device is its mechanical properties matching a predicate device.
- The sample size for the training set: Not applicable. No "training set" in the AI/ML sense.
- How the ground truth for the training set was established: Not applicable.
Summary of Performance Data from the Submission
The document states:
- 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."
This indicates that the safety and effectiveness of the Gender Solutions™ Natural-Knee® Flex System were established through non-clinical mechanical testing, demonstrating its equivalence to predicate devices that have already established safety and efficacy. No human clinical trials or data interpretation studies were required or performed for this particular 510(k) submission. The modifications from the predicate device were described as "dimensional and material modifications," which implies that the fundamental design and function were maintained, justifying the reliance on mechanical testing for substantial equivalence.
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K073286 i/a
Summary of Safety and Effectiveness
MAR - 7 2008
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Brandon Hipsher, RACAssociate Manager, Corporate Regulatory AffairsTelephone: (574) 371-8083Fax: (574) 372-4605 |
| Date: | March 3, 2008 |
| Trade Name: | Gender Solutions TM Natural-Knee ® Flex System |
| Common Name: | Total Knee Prosthesis |
| Classification Nameand Reference: | Knee joint patellofemorotibialpolymer/metal/polymer semiconstrained cementedprosthesis21 CFR § 888.3560Knee joint patellofemorotibial metal/polymerporous-coated uncemented prosthesis21 CFR § 888.3565Knee joint patellofemoral polymer/metalsemiconstrained cemented prosthesis21 CFR § 888.3540 |
| Predicate Devices: | Gender Solutions Natural-Knee Flex System,manufactured by Zimmer, Inc., K070214, clearedMarch 16, 2007.Zimmer Patellofemoral Joint Prosthesis,manufactured by Zimmer, Inc., K070695, clearedJune 7, 2007. |
| Device Description: | The Gender Solutions Natural-Knee Flex (N-KFlex) components are semiconstrained, nonlinkedcondylar knee prosthesis that are designed to have amaximum active flexion of 155 degrees. The N-KFlex femoral provides increased flexion capability |
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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 areindicated for uncemented or cemented use inskeletally mature individuals with intact medialand lateral collateral ligaments undergoingprimary surgery for rehabilitating kneesdamaged as a result of NoninflammatoryDegenerative Joint Disease (NIDJD) orInflammatory Joint Disease (IJD). Components without CSTi porous coating areindicated for cemented use in skeletally matureindividuals with intact medial and lateralcollateral ligaments with conditions ofNoninflammatory Degenerative Joint Disease(NIDJD) or Inflammatory Joint Disease (IJD),correctable varus-valgus deformity andmoderate flexion contracture, or failed previoussurgery where pain, deformity or dysfunctionpersists. |
|---|---|
| Comparison to Predicate Device: | Except for dimensional and material modifications,the subject components are identical to the predicatedevice. |
| Performance Data (Nonclinicaland/or Clinical): | Non-Clinical Performance and Conclusions:Mechanical testing of the subject devicesdemonstrates that they are substantially equivalentto the predicate devices.Clinical Performance and Conclusions:Clinical data and conclusions were not needed forthese devices. |
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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.
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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
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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
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Division of General, Restorative, and Neurological Devices
510(k) Number K073286
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
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).(b)
Classification. Class II.