TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE

K063515 · Biomet Manufacturing, Inc. · HRY · Feb 2, 2007 · Orthopedic

Device Facts

• Record ID: K063515
• Device Name: TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE
• Applicant: Biomet Manufacturing, Inc.
• Product Code: HRY · Orthopedic
• Decision Date: Feb 2, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3530
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Titanium Repicci II® Unicondylar Femoral Knee Components and the CoCr Repicci II® Unicondylar Knee are indicated for 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. These devices are single-use implants intended for implantation with bone cement.

Device Story

Titanium and CoCr unicondylar femoral knee implants; designed for partial replacement of knee articulating surfaces. Available in multiple sizes and anatomical configurations (medial/lateral). Intended for single-use; implanted with bone cement. Used by orthopedic surgeons in clinical settings to treat degenerative joint disease or post-traumatic conditions. Provides structural replacement of damaged femoral condyle surfaces to restore joint function.

Clinical Evidence

No clinical data provided; substantial equivalence based on non-clinical laboratory testing.

Technological Characteristics

Materials: Titanium and Cobalt-Chromium (CoCr). Design: Unicondylar femoral knee components, anatomical, available in multiple sizes and configurations. Energy source: None (passive implant). Sterilization: Not specified. Connectivity: N/A.

Indications for Use

Indicated for partial knee replacement in patients with compartmental primary or post-traumatic degenerative disease, previous tibial condyle/plateau fractures, deformity, or revision of previous arthroplasty affecting only one side of the joint.

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).

Predicate Devices

• Titanium Femoral Knee Components (Maxim® and AGC®) (K041466)
• Repicci II® Unicondylar Knee System (K020264)
• Titanium Femoral Component (K981996)
• Repicci II® Unicondylar Knee (K971938)

Submission Summary (Full Text)

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K063515 1/2

Image /page/0/Picture/1 description: The image shows the word "BIOMET" in a stylized, blocky font. The letters are thick and bold, with the "T" having a unique design where the horizontal bar is made up of three parallel lines. The overall design gives the word a strong and industrial appearance.

## 510(k) Summarv

FEB - 2 2007

Inc. Inc. Inc. Inc.

| Preparation Date: | November 20, 2006 |
|----------------------|------------------------------------------------------------------------------------------------|
| Applicant/Sponsor: | Biomet Manufacturing Corp. |
| Contact Person: | Susan Alexander |
| Proprietary Name: | Titanium Repicci II® Unicondylar Femoral Knee Components<br>CoCr Repicci II® Unicondylar Knee |
| Common Name: | Knee femoral |
| Classification Name: | Prosthesis, Knee Femorotibial, Semi-Constrained, Cemented, Metal/Polymer<br>(21 CFR §888.3530) |

### Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

| Titanium Femoral Knee Components<br>(Maxim® and AGC®) | K041466 | Biomet |
|-------------------------------------------------------|---------|--------|
| Repicci II® Unicondylar Knee System | K020264 | Biomet |
| Titanium Femoral Component | K981996 | Biomet |
| Repicci II® Unicondylar Knee | K971938 | Biomet |

#### Device Description:

The Titanium Repicci II® Unicondylar Femoral Knee Components are medial or lateral unicondylar knee replacement implants available in six sizes. Each size is anatomical in nature and is available in two configurations - one for the medial side of right knees and lateral side of left knees (LL/RM), and one for the lateral side of right knees and the medial side of left knees (RL/LM).

The CoCr Repicci II® Unicondylar Knee (K020264) is available in five sizes. Each size is anatomical in nature and is available in two configurations – one for the medial side of right knees and lateral side of left knees (LL/RM), and one for the lateral side of right knees and the medial side of left knees (RL/LM),

#### Intended Use:

The Titanium Repicci II® Unicondylar Femoral Knee Components and the CoCr Repicci II® Unicondylar Knee are indicated for 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.

These devices are single-use implants intended for implantation with bone cement.

Image /page/0/Figure/13 description: This image shows the mailing address, shipping address, office number, fax number, and email address. The mailing address is P.O. Box 587, Warsaw, IN 46581-0587. The shipping address is 56 E. Bell Drive, Warsaw, IN 46582. The office number is 574.267.6639, the fax number is 574.267.8187, and the email address is [e-mail].

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Summary of Technologies: The technological characteristics (material, design and sizing) of the Titanium Repicci II® Unicondylar Femoral Knee Components and the CoCr Repicci II® Unicondylar Knee Components are similar or identical to the predicate devices. The indications are exactly the same as the predicate Repicci II® Unicondylar knee systems.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc.

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Manufacturing Corp. % Ms. Susan Alexander Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587 FEB - 2 2007

Re: K063515

Trade/Device Name: Titanium Repicci II® Unicondylar Femoral Knee Components and CoCr Repicci II® Unicondylar Knee Components Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HRY Dated: November 20, 2006 Received: November 21, 2006

Dear Ms. Alexander:

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

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Page 2 - Ms. Susan Alexander

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.

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Barbara Brem

Mark N. Melkerson 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): | K063515 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: Titanium Repicci II(® Unicondylar Femoral Knee Components CoCr Repicci II® Unicondylar Knee

Indications For Use:

The Titanium Repicci II(® Unicondylar Femoral Knee Components and CoCr Repicci II(8) Unicondylar Knee are indicated for 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.

These devices are single-use implants intended for implantation with bone cement.

Prescription Use _ x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Snehl D. MCN
(Division Sign. or Org.)

Division of General, Restorative, and Neurological Devices

510(k) Number < 0h3515

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