23 MM SINGLE-PEG PATELLA COMPONENT

K061340 · Biomet Manufacturing, Inc. · JWH · Sep 25, 2006 · Orthopedic

Device Facts

• Record ID: K061340
• Device Name: 23 MM SINGLE-PEG PATELLA COMPONENT
• Applicant: Biomet Manufacturing, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Sep 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 23 mm Single Peg Patella intended use is for replacement of part of the knee joint in conjunction with a femoral and tibial component. Specifically: (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. The device is indicated for cemented application only.

Device Story

23 mm diameter single-peg patella component; dome-shaped with underside grooves; manufactured from ArCom® polyethylene. Intended for surgical implantation as part of a total knee arthroplasty system; requires femoral and tibial components. Device is inset into host patella using bone cement. Used by orthopedic surgeons in clinical settings to restore knee joint function, alleviate pain, and correct deformities in patients with degenerative or traumatic joint disease.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing.

Technological Characteristics

Material: ArCom® polyethylene. Design: 23 mm diameter, single-peg, dome-shaped with underside grooves. Application: Cemented only. No electronic or software components.

Indications for Use

Indicated for patients requiring knee joint replacement due to osteoarthritis, rheumatoid arthritis, traumatic arthritis, or deformity (varus, valgus, posttraumatic), or revision of failed prior procedures. Indicated for cemented application 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

• Vanguard™ Patella (K040770)
• Ultra High Molecular Weight Components Knees (K921182)
• AGC Revision Knee Prosthesis (K912245)

Submission Summary (Full Text)

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K061340

## 510(k) Summary

| Prepared: | September 14, 2006 | SEP 25 2006 |
|----------------------|----------------------------------------------------------------------------------------------------------------|-------------|
| Applicant/Sponsor: | Biomet Manufacturing Corp.<br>P.O. Box 587<br>Warsaw, Indiana 46581-0587 | |
| Contact Person: | Lester F. Padilla | |
| Proprietary Name: | 23 mm Single-Peg Patella Component | |
| Common Name: | Patella Component | |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained<br>cemented prosthesis (21 CFR 888.3560) | |

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

- 1. Vanquard™ Patella (K040770)
- 2. Ultra High Molecular Weight Components Knees (K921182)
- 3. AGC Revision Knee Prosthesis (K912245)

Device Description: The 23 mm Single-Peg Patella Component has the following features: (1) 23 mm diameter with a 1″ true dome shape with grooves on the underside; (2) single-peg design; (3) made with ArCom® polyethylene. The 23 mm Single-Peg Patellae are intended for inset into the host patella only using bone cement

Intended Use: The 23 mm Single Peg Patella intended use is for replacement of part of the knee joint in conjunction with a femoral and tibial component. Specifically: (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. The device is indicated for cemented application only.

Summary of Technologies: The technological characteristics (material, design, sizing, and indications) of the 23 mm Single-Peg Patella Components are similar or identical to the predicate devices.

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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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Manufacturing Corp. % Lester F. Padilla, RAC Regulatory Affairs Associate 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

SEP 2 5 2006

Re: K061340 Trade/Device Name: 23 mm Single-Pêg Patella Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Codes: JWH Dated: September 14, 2006 Received: September 18, 2006

Dear Mr. Padilla:

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. Lester F. Padilla

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 (24 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 Constimer 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,

f
Melkerson

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): | K061340 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: 23 mm Single-Peg Patella Component

Indications for Use:

The 23 mm Single Peg Patella Components intended use is for replacement of part of the knee joint in conjunction with a femoral and tibial component. Specifically:

- 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.

The device is indicated for cemented application only.

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

Over-The-Counter Use _ NO (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)

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Pothin

(Division Sign-Off) Division of General, Restoral A and Neurological Devices

**510(k) Number** kccj24c