NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS

K031962 · Implex Corp. · JWH · Jan 8, 2004 · Orthopedic

Device Facts

• Record ID: K031962
• Device Name: NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS
• Applicant: Implex Corp.
• Product Code: JWH · Orthopedic
• Decision Date: Jan 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NexGen Trabecular Metal Tibial Cone Augments are indicated for use in the reconstruction of bony defects in knee reconstruction due to severe degeneration, trauma, or other pathology of the knee joint, and in the revision or salvage of failed, previously reconstructed knee procedures and implants. The Trabecular Metal Tibial Cone Augments are for cemented use only in the USA, and for cementless or cemented use outside the USA.

Device Story

NexGen Trabecular Metal Tibial Cone Augments are orthopedic implants designed to address proximal tibial cavitary defects. Used in conjunction with Zimmer Legacy Stemmed Tibial Bases (LCCK) and Rotating Hinge Knee (RHK) components. Augments are hollow, tapered, Trabecular Metal structures; filled with bone cement during implantation to secure the tibial base plate stem or keel. Used by orthopedic surgeons in clinical/surgical settings. Provides structural support for tibial base plates in revision knee arthroplasty; benefits patients by restoring bone stock and enabling stable fixation in complex revision scenarios.

Clinical Evidence

No clinical data. Substantial equivalence supported by engineering analysis and previous testing of Trabecular Metal devices.

Technological Characteristics

Material: Trabecular Metal. Design: Hollow, tapered augment with posterior, medial, and lateral walls. Fixation: Bone cement (USA). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring knee reconstruction due to severe degeneration, trauma, or other joint pathology, including revision or salvage of failed prior knee procedures/implants. Contraindicated for non-cemented use in the USA.

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

• Legacy Stemmed Tibial Bases (LCCK)
• Rotating Hinge Knee (RHK)

Submission Summary (Full Text)

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K031962

JAN - 8 2004 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS NexGen Trabecular Metal Tibial Cone Augments

| Submitter Name<br>And Address: | Implex Corp.<br>80 Commerce Drive<br>Allendale, New Jersey 07401-1600 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Marci Halevi |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Date Prepared: | October 9, 2003 |
| Device Trade Name: | NexGen Trabecular Metal Tibial Cone Augments |
| Device Common Name: | Knee System Augments |
| Classification Number<br>and Name: | 21 CFR § 888.3560<br>Knee joint patellofemorotibial polymer/metal/polymer semi-<br>constrained cemented prosthesis. |

term "substantial equivalence" as used in this 510(k) Substantial The Equivalence: notification is limited to the definition of 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 or their application by the courts.

Device The NexGen Trabecular Metal Tibial Cone Augments are Description: designed to be used in conjunction with Zimmer Inc.'s Legacy@ Stemmed Tibial Bases (LCCK) and Rotating Hinge Knee (RHK) tibial components. The subject devices are used to address proximal tibial cavitary defects encountered when implanting either of these two systems. The augments are manufactured from Trabecular Metal and have tapered posterior, medial and The periphery of the inferior surface is smaller lateral walls. than that of the superior surface. The augments are hollow such that they are to be filled with bone cement, and allow for placement of the stem and/or keel of the associated tibial base plate. Fixation of the augment to the tibial baseplate is accomplished by using bone cement. The inferior surface of the LCCK and RHK tibial baseplates must be cemented to bone.

> The Trabecular Metal Tibial Cone Augments are for cemented use along the bone in the USA, and for cementless or cemented use along the bone outside the USA.

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## 510(k) Summary (Continued)

Indications for Use: The NexGen Trabecular Metal Tibial Cone Augments are indicated for use in the reconstruction of bony defects in knee reconstruction due to severe degeneration, trauma, or other pathology of the knee joint, and in the revision or salvage of failed, previously reconstructed knee procedures and implants. The Trabecular Metal Tibial Cone Augments are for cemented use only in the USA, and for cementless or cemented use outside the USA. Device Technological A comparison of device technological characteristics and Characteristics and properties demonstrates that the device is substantial Comparison to equivalent to the cited predicate devices. Predicate Device: Performance Data: Testing of the subject devices were not performed. Previous testing of Trabecular Metal and Trabecular Metal devices support a determination of substantial equivalence. An engineering analysis was provided to support this (reference Appendix A of the addendum.

- Conclusion: The NexGen Trabecular Metal Tibial Cone Augments are substantially equivalent to the predicate devices identified in this premarket notification.

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 8 2004

Ms. Marci IIalevi Manager of Regulatory Affairs Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401-1600

Rc: K031962

Trade/Device Name: NexGen Trabecular Metal Tibial Conc Augments 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: October 9, 2003 Received: October 10, 2003

Dear Ms. Halevi:

We have reviewed your Section 510(k) premarket notification of intent to market the device w one re revealed 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 cnactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Fedcral Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and connette for (10) was the device, subject to the general controls provisions of the Act. The r ou may, diere, were, mains of the Act include requirements for annual registration, Insting of general voltation province, labeling, and prohibitions against misbranding and adulteration.

ff your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elaintined toonal controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, IDA may publish further announcements concerning your device in the Fedcral 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 or uny reature and 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Marci Halevi

This letter will allow you to begin marketing your device as described in your Section 510(k) This tetter will anow you'ls cognifinding of substantial equivalence of your device to a legally prematicated 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 n you dobile of Compliance at [phone]. Also, please note the regulation entitled, eontact the Oriece of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small (Anergeneral 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. Milliman

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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Implex Corp

510(k) Number (if known) :

KO31962

Device Name:

The NexGen Trabecular Metal Tibial Cone Augments

Indications For Use:

The NexGen Trabecular Metal Tibial Cone Augments are indicated for use in the reconstruction of bony defects in knee reconstruction due to severe degeneration, trauma, or other pathology of the knee joint, and in the revision or salvage of failed, previously reconstructed knee procedures and implants. The Trabecular Metal Tibial Cone Augments are for cemented use only in the USA, and for cementless or cemented use outside the USA.

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Concurrence of CDRH; Office of Device Evaluation (ODE)

Prescripti
on Use
(Per 21 CFR 801.109)

OR...

Over-The-
Counter Use

for Male n
(Optional Format 1-2-96)

vision Sig
Prision of C Restorative
And Neurolo... Devices

100 Num K031962