THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0

K012866 · Implex Corp. · JWH · Sep 26, 2001 · Orthopedic

Device Facts

• Record ID: K012866
• Device Name: THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0
• Applicant: Implex Corp.
• Product Code: JWH · Orthopedic
• Decision Date: Sep 26, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NexGen TMT Tibia is intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty.

Device Story

NexGen TMT Tibia is a prosthetic knee component; manufactured from Trabecular Metal (Hedrocel porous tantalum) with direct compression-molded UHMWPE. Designed for use with Zimmer NexGen CR Femoral Components in cemented total knee arthroplasty. Implanted by orthopedic surgeons in hospital/OR settings. Provides articular surface for knee joint; restores joint function; alleviates pain from severe degeneration or trauma.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Trabecular Metal (Hedrocel porous tantalum) and UHMWPE. Design: Tibial component for cemented total knee arthroplasty. Connectivity: None. Software: None.

Indications for Use

Indicated for patients with severe knee joint degeneration, trauma, or other pathology requiring cemented total knee arthroplasty.

Regulatory Classification

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).

Reference Devices

• Zimmer NexGen CR Femoral Components

Submission Summary (Full Text)

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Implex Corp.

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

The NexGen TMT Tibia Submitter Name: Implex Corp. Submitter Address: 80 Commerce Drive Allendale, New Jersey 07401-1600 Robert A. Poggie, Ph.D. Contact Person: [phone] Phone Number: Fax Number: [phone] August 2, 2001 Date Prepared: The NexGen TMT Tibia Device Trade Name: Device Common Articular Surface and Tibial Components Name: Classification Number 21 CFR § 888.3560 and Name: Substantial The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of Equivalence: substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws

- Device Description: The NexGen TMT Tibia is manufactured from Trabecular Metal (Hedrocel Porous Tantalum) with direct compression molded ultra-high molecular weight polyethylene (UHMWPE).
or their application by the courts.

These tibial components are intended for use with Zimmer NexGen CR Femoral Components.

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## 510(k) Summary (Continued)

The NexGen TMT Tibia is intended for use where severe Indications for Use: degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty.

The NexGen TMT Tibia is substantially equivalent to the Conclusion: identified predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 2 6 2001

Dr. Robert A. Poggie Director of Applied Research Implex Corp. 80 Commerce Drive. Allendale, New Jersey 07401

Re: K012866

Trade/Device Name: The NEXGEN® TMT Tibia Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. Regulatory Class: II

Product Code: JWH Dated: August 24, 2001 Received: August 27, 2001

Dear Dr. Poggie:

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 - Dr. Robert A. Poggie

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Mark A. Milliken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NexGen® TMT Tibia Special 510(k) Premarket Notification

510(k) Number (if known) :

012866

Device Name:

The NexGen® TMT Tibia

Indications For Use:

NexGen® TMT Tibia is intended for use where severe The degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty.

Mark n Melkerson

(Division eral, Restorative Division levices and Neu

510(k) N

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Concurrence of CDRH; Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR . . .

Over-The-Counter Use

(Optional Format 1-2-96)