NEXGEN PROLONG ALL-POLY PATELLA

K072281 · Zimmer, Inc. · JWH · Sep 6, 2007 · Orthopedic

Device Facts

• Record ID: K072281
• Device Name: NEXGEN PROLONG ALL-POLY PATELLA
• Applicant: Zimmer, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Sep 6, 2007
• 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. This device is indicated for cemented use only.

Device Story

NexGen Prolong All-Poly Patella is a component of the NexGen semiconstrained, nonlinked knee prosthesis system. Device replaces damaged patellar surface in total knee arthroplasty. Implanted by orthopedic surgeons in clinical/hospital settings. Device functions as a mechanical bearing surface to restore joint function and alleviate pain. Modification from predicate involves material change only; design and fundamental technology remain identical. Cemented fixation required.

Clinical Evidence

No clinical data provided; substantial equivalence supported by non-clinical performance testing and design assurance processes.

Technological Characteristics

Semiconstrained, cemented knee prosthesis component. Material: All-polyethylene. Design: Identical to predicate NexGen system. Intended for use in patellofemoral joint reconstruction.

Indications for Use

Indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle, post-traumatic joint configuration loss, or moderate valgus/varus/flexion deformities. Also indicated for salvage of failed surgical attempts or knee instability. Cemented use only.

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

• NexGen Knee System (K933785)

Submission Summary (Full Text)

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# K072281 lpg1/2)

## SEP - 6 2007

### Summary of Safety and Effectiveness

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Brandon Hipsher, RAC<br>Senior Associate, Corporate Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | August 15, 2007 |
| Trade Name: | <i>NexGen</i> ^® <i> Prolong</i> ™ All-Poly Patella |
| Common Name: | Total Knee Prosthesis |
| Classification Name<br>and Reference: | Knee joint patellofemorotibial metal/polymer/metal<br>semiconstrained cemented prosthesis<br>21 CFR § 888.3560 |
| Predicate Device: | <i>NexGen</i> Knee System, manufactured by Zimmer,<br>Inc., K933785, cleared January 30, 1995 |
| Device Description: | The proposed device is part of the <i>NexGen</i> system<br>of semiconstrained, nonlinked knee prostheses. |
| 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 necrosis<br>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>This device is indicated for cemented use only. |

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## K072281 (pg 212)

#### Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

Except for a change in material, the NexGen Prolong All-Poly Patella is identical to the predicate device. This modification does not change the intended use or fundamental scientific technology.

Non-Clinical Performance and Conclusions:

Performance testing completed as part of the design assurance process demonstrated that this device is safe and effective and is substantially equivalent to the predicate device.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

SEP - 6 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zimmer, Inc. % Mr. Brandon Hipsher, RAC Senior Associate, Corporate Regulatory Affairs P.O. Box 708 Warsaw. IN 46581

Re: K072281 Trade/Device Name: NexGen® Prolong™ All-Poly Patella Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer Semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: August 15, 2007 Received: August 16, 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 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, RAC

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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbere Buchur

Mark N. Me kerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## h072281 lpg 1/1)

#### Indications for Use

510(k) Number (if known):

Device Name:

NexGen® Prolong™ All-Poly Patella

#### Indications for Use:

- · This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. l
- Collagen disorders and/or avascular necrosis of the femoral condyle. The ।
- 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.
- · This device is indicated for cemented use only.

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)

Aubane Buchs
Division Sign-Off

Division of Ge I. Zestorauve. and Neurological Devices

510(k) Number K072281

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