ASCENT ALL-POLY PS TIBIAL BEARINGS

K021559 · Biomet, Inc. · JWH · Jun 5, 2002 · Orthopedic

Device Facts

• Record ID: K021559
• Device Name: ASCENT ALL-POLY PS TIBIAL BEARINGS
• Applicant: Biomet, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Jun 5, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ascent™ All-Poly PS Tibial Bearings are for the painful and disabled knee joint resulting form osteoarthritis, theumatoid arthritis, traumatic arthritis where one or more compartments are involved; the correction of varus, valgus, or posttraumatic deformity; and the correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. This device is for use with bone cement.

Device Story

Ascent™ All-Poly PS Tibial Bearing is a one-piece posterior stabilized (PS) tibial component used in total knee arthroplasty. Manufactured from ArCom® ultra-high molecular weight polyethylene (UHMWPE); designed for use with Ascent™ Femoral Components. Implanted by orthopedic surgeons in a clinical/surgical setting to replace damaged knee joint surfaces. Device functions as a bearing surface in a semi-constrained, cemented knee prosthesis system. Benefits include pain relief and restoration of joint function for patients with degenerative or traumatic knee conditions. Output is a physical mechanical interface for the knee joint; clinical decision-making relies on surgeon assessment of patient anatomy and joint pathology.

Clinical Evidence

No clinical testing was provided. Substantial equivalence was established based on non-clinical engineering justifications and Finite Element Analysis (FEA).

Technological Characteristics

Material: ArCom® ultra-high molecular weight polyethylene (UHMWPE). Design: One-piece posterior stabilized (PS) tibial bearing. Configuration: Semi-constrained, cemented, polymer/metal/polymer knee prosthesis. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients with painful and disabled knee joints due to osteoarthritis, rheumatoid arthritis, or traumatic arthritis involving one or more compartments; patients requiring correction of varus, valgus, or posttraumatic deformity; and patients requiring correction or revision of unsuccessful osteotomy, arthrodesis, or failed 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

• Kirschner Performance Total Knee System (K934589)

Reference Devices

• Ascent™ Femoral Components (K982869)

Submission Summary (Full Text)

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JUN 0 5 2002

021559

# CORPORATE UARTERS

## SUMMARY OF SAFETY AND EFFECTIVENESS

| Applicant or Sponsor: | Biomet Orthopedics, Inc.<br>P.O. Box 587<br>Warsaw, IN 46581-0587 |
|-----------------------|-------------------------------------------------------------------|
| Contact Person: | Dalene T. Binkley<br>Telephone: [phone] |
| Proprietary Name: | Ascent™ All-Poly PS Tibial Bearing |
| Common Name: | All-Polyethylene Tibial Bearing |

Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (21 CFR 888.3560)

Device Classification: Class II

Legally Marketed Device to which Substantially Equivalence is Claimed: Kirschner Performance Total Knee System (K934589).

Device Description: The Ascent™ All-Poly PS Tibial Bearings are manufactured from ArCom®, an ultra-high molecular weight polyethylene (UHMWPE). The one-piece posterior stabilized (PS) tibial components are available in varying thicknesses and widths.

The Ascent™ All-Poly PS Tibial Bearings are used in conjunction with the Ascent™ Femoral Components (K982869).

Indications for Use: The indications for the Ascent™ All-Poly PS Tibial Bearings are for painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; the correction of varus, valgus, or posttraumatic deformity; and the correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The Ascent™ All-Poly PS Tibial Bearings are for use with bone cement.

Summary of Technologies: The Ascent™ All-Poly PS Tibial Bearings -the materials, design, sizing, and indications are similar or identical to the predicate devices.

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

> > .

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

OFFICE 219.267.6639 FAX [phone] 000038

E-MAIL [e-mail]

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Summary of Safety & Effectiveness All-Polyethylene Tibial Bearing Page 2

Non-Clinical Testing: Engineering Justifications and a Finite Element Analysis (FEA) determined that the Ascent All-Poly PS Tibial Bearings presented no new risks and were, therefore, substantially equivalent to the predicate device.

Clinical Testing: No clinical testing was provided as a basis for substantial equivalence.

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

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SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

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**000039**
**0000**

OFFICE 219.267.6639

FAX [phone]

E-MAIL [e-mail]

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

JUN 0 5 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Dalene T. Binkley Regulatory Affairs Specialist Biomet, Inc. P.O. Box 587 Warsaw, IN 46581-0587

Re: K021559

Trade Name: Ascent™ All-Poly PS Tibial Bearings Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: May 6, 2002 Received: May 13, 2002

Dear Ms. Binkley:

We have reviewed your Section 510(k) premarket 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) 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 - Ms. Dalene T. Binkley

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 and additionally 21 CFR Part 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" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours.

Sincerely yours,

Mark N Melkenson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

## 510 (k) NUMBER (IF KNOWN): _ kod | 559

DEVICE NAME: Ascent™ All-Poly PS Tibial Bearings

INDICATIONS FOR USE:

The Ascent™ All-Poly PS Tibial Bearings are for the painful and disabled knee joint resulting form osteoarthritis, theumatoid arthritis, traumatic arthritis where one or more compartments are involved; the correction of varus, valgus, or posttraumatic deformity; and the 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 (Per 21 CFR 801.109) OR

Mark N. Milkman

Restorative and North of Callerical Devices

510(k) Number

Over-The-Counter-Use (Optional Format 1-2-96)

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