REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS

K980665 · Biomet, Inc. · HRY · May 20, 1998 · Orthopedic

Device Facts

• Record ID: K980665
• Device Name: REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS
• Applicant: Biomet, Inc.
• Product Code: HRY · Orthopedic
• Decision Date: May 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3530
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. The device is a single use implant intended for implantation with bone cement. The devices covered by this 510(k) are intended to be used with a Repicci Femoral component.

Device Story

Repicci II Unicondylar Knee All Poly Tibial Component is a single-use orthopedic implant for partial knee replacement. Device consists of a universal-geometry polyethylene tibial component featuring a waffle pattern and recessed holes on the undersurface to facilitate fixation with bone cement. A wire is molded within the polyethylene to provide radiopacity. Intended for use with a Repicci Femoral component in patients with compartmental degenerative disease or post-traumatic conditions. Implanted by orthopedic surgeons in a clinical/surgical setting. Provides a bearing surface for the knee joint to restore function and reduce pain associated with joint degeneration.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use characteristics consistent with legally marketed predicate devices.

Technological Characteristics

Material: Polyethylene (all-poly). Design: Universal geometry (left/right interchangeable). Fixation: Cemented only. Radiopacity: Embedded wire. Form factor: Tibial component with waffle pattern and recessed holes for cement interlock. Minimum thickness: 6.5mm.

Indications for Use

Indicated for patients requiring partial knee replacement due to compartmental primary or post-traumatic degenerative disease, previous tibial condyle/plateau fractures, deformity, or revision of previous arthroplasty. Contraindicated for non-cemented use.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

Sponsor: Biomet. Inc. Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0578

K980665

Repicci II Unicondylar Knee All Poly Tibial Components Device:

Classification Name: Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/Polymer (21 CFR 888.3530)

Intended Use: Partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. The device is a single use implant intended for implantation with bone cement. The devices covered by this 510(k) are intended to be used with a Repicci Femoral component.

Device Description: The Repicci II Unicondylar Knee system consists of a femoral and tibial component. The femoral components have been cleared through a previous 510(k) as have thicker sizes of the all poly tibial component.

The all polvethylene tibial component is universal in geometry so separate components are not necessary for left and right knees. A waffle pattern and recessed holes on the under surface assists in fixation with bone cement. Due to the radiolucency of polyethylene, a wire is molded within the component.

Potential Risks: The potential risks associated with this device are the same as with any ioint replacement device. These include, but are not limited to:

Reaction to the bone cement Deformity of the joint Cardiovascular disorders Fracture of the cement Implant loosening/migration Nerve damage

Blood vessel damage Soft tissue imbalance Delayed wound healing Metal sensitivity Fracture of the components Bone fracture Infection Hematoma Dislocation Excessive wear

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

1

SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580

OFFICE 219.267.6639

FAX
219.267.8137
**000027**

E-MAIL [e-mail]

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Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 20 1998

Ms. Patricia Sandborn Beres Director, Regulatory Affairs Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re : K980665 Repicci II Unicondylar Knee All Poly Tibial Components Regulatory Class: II Product Code: HRY February 18, Dated: 1998 February 20, 1998 Received:

Dear Ms. Beres:

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). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the general controls provisions of the Act and the following limitations:

- The thinnest tibial component available is the nominal 1. "6.5mm" sized component, which has a minimum polyethylene thickness of 6.5mm
- 2. This device may not be labeled or promoted for noncemented use.
- 3. All labeling for this device, including package label and labeling included within the package, must prominently state that the device is intended for cemented use only.

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## Page 2 - Ms. Patricia Sandborn Beres

- Any non-cemented fixation of this device is considered র্ব . investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for noncemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investiqation.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, 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 Requlations, Title 21, Parts 800 to 895. ದ 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 In addition, FDA may publish further announcements action. 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.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 addition ly 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

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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: Repicci II Unicondylar Knee All Poly Tibial Components_

## Indications For Use:

Partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or posttraumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

The devices covered by this 510(k) are intended to be used with a Repicci Femoral component .

The device is a single use implant intended for implantation with bone cement.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDBO)

Concurrence of CDRH, Office of Device - Juation (ODE)

| Prescription Use | X | OR | Over-The-Counter Use | |
|----------------------|---|----|--------------------------|--|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) | |

(Division Sign-Off)

Division of General Restorative Devices

| 510(k) Number | K980665 |
|---------------|---------|
|---------------|---------|