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 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.
The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

Device Description

The Gender Solutions Natural-Knee Flex System is a semiconstrained, nonlinked condylar knee prosthesis that is designed to have a maximum active flexion of 155 degrees. The system includes GSM and GSF femoral components; these designations indicate that the design of the femoral components has been modified to address specific anatomical features of the distal femur that can be seen in patients of either gender, but are more typical of male and female patients, respectively.

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.

The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

Except for minor geometrical and material modifications, the proposed components are identical to the predicate devices.

AI/ML Overview

The provided document describes the Zimmer Gender Solutions™ Natural-Knee® Flex System, which is a total knee prosthesis. It details the device's description, indications for use, and a comparison to predicate devices. However, it explicitly states:

"Clinical data and conclusions were not needed for this device."

This type of submission (510(k)) relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies to prove safety and effectiveness from scratch. Therefore, the information you've requested regarding acceptance criteria based on a clinical study, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance does not exist within this document for this specific device.

The document primarily focuses on:

Substantial Equivalence: The approval is based on the device being substantially equivalent to the NexGen® Complete Knee Solution Knee Gender Solutions Female (GSF) Femoral Components and Natural-Knee II System with Cancellous-Structured Titanium™ (CSTi™) Porous Coating.
Non-Clinical Performance: "Mechanical testing and Finite Element Analysis of the proposed device demonstrates that it is substantially equivalent to the predicate devices." This likely covers aspects like strength, wear, and other physical properties.

Summary of Requested Information (Based on the Provided Document):

Since no clinical study was needed or performed for this device's 510(k) clearance, most of the requested fields cannot be filled.

Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as performance metrics from a clinical study for this device, but implied to be "substantially equivalent" to predicate devices based on non-clinical testing.
- Reported Device Performance: Not reported from a clinical study for this device. Mechanical testing and Finite Element Analysis indicated substantial equivalence to predicate devices.
Sample sized used for the test set and the data provenance: Not applicable as no clinical test set was used for this 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set was used for this 510(k) submission.
Adjudication method for the test set: Not applicable as no clinical test set was used for this 510(k) submission.
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 device is a physical knee prosthesis, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical knee prosthesis, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no clinical ground truth was established for this device's 510(k) submission. The "ground truth" for clearance was the established safety and effectiveness of the predicate devices.
The sample size for the training set: Not applicable as no training set (in the context of machine learning or clinical trials) was used for this 510(k) submission.
How the ground truth for the training set was established: Not applicable as no training set was used for this 510(k) submission.

In essence, the "study that proves the device meets the acceptance criteria" in this case is the non-clinical mechanical testing and Finite Element Analysis that demonstrated the device's substantial equivalence to already cleared predicate devices. The acceptance criteria were met by showing that the new device performs similarly in terms of its mechanical properties and design to devices already established as safe and effective.

Summary

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MAR 1 6 2007

Summary of Safety and Effectiveness

....

Submitter:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Brandon Hipsher, RACSenior Associate, Corporate Regulatory AffairsTelephone: (574) 371-8083Fax: (574) 372-4605
Date:	January 22, 2007
Trade Name:	Gender Solutions™ 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 § 888.3565
Predicate Devices:	NexGen® Complete Knee Solution Knee GenderSolutions Female (GSF) Femoral Components,manufactured by Zimmer, Inc., K060370, clearedApril 28, 2006.Natural-Knee II System with Cancellous-StructuredTitanium™ (CSTi™) Porous Coating, manufactured1997 and reclassified to Class II February 3, 2003.Prolong™ Highly Crosslinked PolyethyleneCruciate Retaining Articular Surface Component.December 27, 2001.

Device Description:

The Gender Solutions Natural-Knee Flex System is a semiconstrained, nonlinked condylar knee

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prosthesis that is designed to have a maximum active flexion of 155 degrees. The system includes GSM and GSF femoral components; these designations indicate that the design of the femoral components has been modified to address specific anatomical features of the distal femur that can be seen in patients of either gender, but are more typical of male and female patients, respectively.

Except for minor geometrical and material modifications, the proposed components are identical to the predicate devices.

Non-Clinical Performance and Conclusions:

Mechanical testing and Finite Element Analysis of the proposed device demonstrates that it is substantially equivalent to the predicate devices.

Clinical Performance and Conclusions:

Intended Use:

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

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Clinical data and conclusions were not needed for this device.

. . . .

100 million and

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 16 2007

Zimmer, Inc. % Brandon Hipsher, RAC P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K070214

Trade/Device Name: Gender Solutions Natural-Knee Flex System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: March 8, 2007 Received: March 9, 2007

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

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Page 2 - Mr. Brandon Hipsher, RAC

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. 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Aubrey Muchno

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): K070214

Device Name:

Gender Solutions™ Natural-Knee® Flex System

Indications for Use:

· 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 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.
· The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

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)

Daulace Buem

(Division Sign-Oli) Division of General, Restorative, and Neurological Devices

510(k) Number K070214

Page 1 of 1

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.