NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACES

K042271 · Zimmer, Inc. · JWH · Oct 13, 2004 · Orthopedic

Device Facts

• Record ID: K042271
• Device Name: NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACES
• Applicant: Zimmer, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Oct 13, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. - Collagen disorders, and/or avascular necrosis of the femoral condyle. - Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy - Moderate valgus, varus, or flexion deformities. - The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. The device is indicated for use when both cruciate ligaments have been excised. The device is intended for use as part of a cemented or uncemented knee prosthesis.

Device Story

NexGen LPS-Flex Prolong articular surfaces are components of a total knee prosthesis system. Device replaces damaged joint surfaces in patients with severe knee pain/disability. Components are manufactured from highly crosslinked polyethylene. Device is used in orthopedic surgery; implanted by surgeons. Functions as a bearing surface within a semiconstrained knee prosthesis system; provides stability in flexion when both cruciate ligaments are excised. Benefits include restoration of joint function and pain relief. Device is substantially equivalent to existing NexGen components, utilizing similar design and materials with minor dimensional modifications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Articular surface components made of highly crosslinked polyethylene. Semiconstrained design for patellofemoral/tibial use. Compatible with cemented or uncemented femoral and tibial baseplate components.

Indications for Use

Indicated for patients with severe knee pain and disability due to rheumatoid, osteoarthritis, traumatic, or polyarthritis; collagen disorders; avascular necrosis of femoral condyle; post-traumatic joint loss; or moderate valgus, varus, or flexion deformities. Indicated for salvage of failed surgical attempts or cases requiring stability in flexion. Indicated for use when both cruciate ligaments are excised.

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).

Predicate Devices

• LPS-Flex Fixed Bearing Articular Surface Components (K991581)
• Prolong Highly Crosslinked Polyethylene Cruciate Retaining (CR) Articular Surface Components (K013991)
• NexGen Porous, Uncemented Femoral and Tibial Baseplate Components (K031061)

Submission Summary (Full Text)

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007 1 3 2004

## Summary of Safety and Effectiveness

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Brandon Hipsher<br>Specialist, Corporate Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | October 12, 2004 |
| Trade Name: | NexGen® Complete Knee Solution LPS-Flex<br>Prolong™ Highly Crosslinked Polyethylene<br>Articular Surfaces |
| Common Name: | Total Knee Prosthesis |
| Classification Name<br>and Reference: | Knee joint patellofemorotibial polymer/metal/<br>polymer semi-constrained cemented prosthesis<br>21 CFR § 888.3560 (JWH)<br>Knee joint patellofemorotibial metal/polymer<br>porous-coated uncemented prosthesis<br>21 CFR § 888.3565 (MBH) |
| Predicate Devices: | LPS-Flex Fixed Bearing Articular Surface<br>Components, manufactured by Zimmer, Inc.,<br>K991581, cleared July 30, 1999.<br><br>Prolong Highly Crosslinked Polyethylene Cruciate<br>Retaining (CR) Articular Surface Components,<br>manufactured by Zimmer, Inc., K013991, cleared<br>December 27, 2001.<br><br>NexGen Porous, Uncemented Femoral and Tibial<br>Baseplate Components, manufactured by Zimmer,<br>Inc., K031061, cleared October 9, 2003. |
| Device Description: | The NexGen LPS-Flex Prolong articular surfaces<br>are part of the NexGen system of semiconstrained, |
| Intended Use: | This device is indicated for patients with severe<br>knee pain and disability due to:<br>- Rheumatoid arthritis, osteoarthritis,<br>traumatic arthritis, polyarthritis.<br>- Collagen disorders, and/or avascular<br>necrosis of the femoral condyle.<br>- Post-traumatic loss of joint configuration,<br>particularly when there is patellofemoral<br>erosion, dysfunction or prior patellectomy<br>- Moderate valgus, varus, or flexion<br>deformities.<br>- The salvage of previously failed surgical<br>attempts or for a knee in which satisfactory<br>stability in flexion cannot be obtained at the<br>time of surgery.<br>The device is indicated for use when both cruciate<br>ligaments have been excised.<br>The device is intended for use as part of a cemented<br>or uncemented knee prosthesis. |
| Comparison to Predicate Device: | Except for a change in material and minor<br>dimensional modifications, LPS-Flex Prolong<br>articular surfaces are identical to the predicate<br>device. The modifications do not change the<br>intended use or the fundamental scientific<br>technology. The device is packaged using the same<br>materials and processes. |
| Performance Data (Nonclinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions:<br>Performance testing completed as part of the design<br>assurance process demonstrated that this device is<br>safe and effective and substantially equivalent to the<br>predicate device.<br>Clinical Performance and Conclusions:<br>Clinical data and conclusions were not needed for<br>this device. |

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle, with its wings spread and its head turned to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 3 2004

Mr. Brandon Hipsher Specialist, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K042271

K042271
Trade/Device Name: NexGen® Complete Knee Solution LPS-Flex Prolong™ Highly Crosslinked Polyethylene Articular Surfaces Regulation Number: 21 CFR 888.3560 and 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis and Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: II Product Code: JWH and MBH

Dated: September 10, 2004 Received: September 13, 2004

### Dear Mr. Hipsher

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bector. 910(s) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreate) to ttg_as) actment date of the Medical Device Amendments, or to commence prices that have been reclassified in accordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic 710-1710-11-28, subject to the general controls provisions of the Act. The Tourmay, therefore, thanket the act include requirements for annual registration, listing of general controlly provisions 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 If your device is classified (800 aborto) als. Existing major regulations affecting your device can may be subject to suen additional begulations, 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 I loase oe actived that I be mination that your device complies with other requirements of the Act that I Dri has made a assocd regulations administered by other Federal agencies. You must

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## Page 2 - Mr. Brandon Hipsher

comply with all the Act's requirements, including, but not limited to: registration and listing (21 comply with an the rice s requirements, 01); good manufacturing practice requirements as set CITY art 8077, adoling (21 CFR Part 820); and if applicable, the electronic forul in the qualis) byevelsions (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) This iciter will anow you to ogen mailing of substantial equivalence of your device to a legally premits to the nevice 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 If you desire specific acvice 10. Jour acon 2011) 276-0120. Also, please note the regulation entitled, contact the Office of Computer in (Et notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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. Millican

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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## Indications for Use

# 510(k) Number (if known): Ko4227 |

#### Device Name:

NexGen® Complete Knee Solution LPS-Flex Prolong™ Highly Crosslinked Polyethylene Articular Surfaces

#### Indications for Use:

This device is indicated for patients with severe knee pain and disability due to:

- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. -
- Collagen disorders and/or avascular necrosis of the femoral condyle. ।
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
- Moderate valgus, varus or flexion deformities. -
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

The device is indicated for use when both cruciate ligaments have been excised. The device is intended for use as part of a cemented or uncemented knee prosthesis.

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)

R. Mark A. Millauer

Sion-(){}) Division of General, Restorative, and Neurological Devices

K04227

**510(k) Number**_

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