PERFORMANCE KNEE SYSTEM

K992167 · Biomet, Inc. · JWH · Jul 28, 1999 · Orthopedic

Device Facts

• Record ID: K992167
• Device Name: PERFORMANCE KNEE SYSTEM
• Applicant: Biomet, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Jul 28, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Performance Knee System is indicated for use: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure or previous joint replacement procedure. The device is intended for use with bone cement.

Device Story

Performance Knee System includes modular femoral augmentation blocks (FAB) used to address bone loss or fit requirements in knee arthroplasty. Blocks are manufactured from titanium (Ti-6Al-4V) alloy; fastened to femoral knee component via locking screw. Used individually or in combinations to match femoral component size. Intended for use by orthopedic surgeons in clinical settings during total knee replacement procedures. Device provides structural augmentation to the femoral component, facilitating joint reconstruction and stability. Benefits include improved implant fit and correction of complex deformities.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Modular femoral augmentation blocks; material: titanium (Ti-6Al-4V) alloy; fixation: locking screw to femoral component; intended for use with bone cement.

Indications for Use

Indicated for patients with painful/disabled knee joints due to osteoarthritis, rheumatoid arthritis, or traumatic arthritis; patients requiring correction of varus, valgus, or posttraumatic deformity; and patients requiring revision of failed osteotomy, arthrodesis, or previous joint replacement. For use with bone cement.

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

• Performance Knee System

Submission Summary (Full Text)

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K992167

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### Summary of Safety and Effectiveness

| Sponsor: | Biomet, Inc.<br>Airport Industrial Park<br>P.O. Box 587<br>Warsaw, Indiana 46581-0587 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michelle L. McKinley |
| Device: | Performance Knee System |
| Classification: | 87JWH |
| Intended Use: | The Performance Knee System is indicated for use:<br><ol><li>Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.</li><li>Correction of varus, valgus, or posttraumatic deformity.</li><li>Correction or revision of unsuccessful osteotomy, arthrodesis, or failure or previous joint replacement procedure.</li></ol> The device is intended for use with bone cement. |
| Device Description: | The femoral augmentation blocks (FAB) may be used individually or in combinations; in a variety of positions to create an implant that fits the patient's needs. The modular femoral augmentation blocks are fastened to the femoral knee component with a locking screw. Femoral augmentation blocks are manufactured from titanium (Ti-6Al-4V) alloy with the geometry to match a corresponding size femoral component. |
| Potential Risks: | The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to: |

| Reaction of bone cement | Blood vessel damage | Bone fracture |
|-----------------------------|----------------------------|----------------|
| Deformity of the joint | Soft tissue imbalance | Infection |
| Cardiovascular disease | Delayed wound healing | Hematoma |
| Fracture of the cement | Metal sensitivity | Dislocation |
| Implant loosening/migration | Fracture of the components | Excessive wear |
| Tissue growth failure | Nerve damage | |

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## Substantial Equivalence:

Direct comparison was made with the following predicate:

Performance Knee System

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 28 1999

Ms. Michelle L. McKinley Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K992167

> Trade Name: Performance Knee System- Femoral Augmentation Blocks Regulatory Class: II Product Code: JWH Dated: June 21, 1999 Received: June 28, 1999

Dear Ms. McKinley:

We have reviewed your Section 510(k) notification of intent to market the device referenced above, and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Michelle L. McKinley

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) NUMBER (IF KNOWN):_____________________________________________________________________________________________________________________________________________________

DEVICE NAME: Performance Knee System

INDICATIONS FOR USE:

The Performance Knee is indicated for use:

- 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
- 2. Correction of varus, valgus, or posttraumatic deformity.
- 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

This device is for use with bone cement.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align:center;">X</div> |
|------------------------------------------|-----------------------------------------|
|------------------------------------------|-----------------------------------------|

OR

| Over-The-Counter-Use<br>(Optional Format 1-2-96) | |
|--------------------------------------------------|--|
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(Division Sign-Off)(Division Sign-Off)
Division of General Restorative Devices, (992167
510(k) Number.

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