MAXIM ACCEL (VANGUARD) PS+ BEARINGS

K041046 · Biomet, Inc. · JWH · May 21, 2004 · Orthopedic

Device Facts

• Record ID: K041046
• Device Name: MAXIM ACCEL (VANGUARD) PS+ BEARINGS
• Applicant: Biomet, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: May 21, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Maxim® Accel (Vanguard™) PS+ Bearings are posterior stabilized (PS) knee joint inserts; designed to replace articular portions of knee joint; limits axial and varus/valgus rotation. Implanted by orthopedic surgeons in clinical/hospital settings; requires bone cement for fixation. Device serves as a component in total knee arthroplasty; restores joint function; alleviates pain; corrects deformities. Single-use implant.

Clinical Evidence

No clinical data provided as a basis for substantial equivalence; non-clinical laboratory testing performed to demonstrate functionality.

Technological Characteristics

Cemented semi-constrained polymer/metal/polymer knee prosthesis. Posterior stabilized (PS) bearing design. Single-use implant. Intended for use with bone cement.

Indications for Use

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

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

• Maxim® Accel Knee System (K023546)

Submission Summary (Full Text)

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### 510(k) Summary

| Sponsor: | Biomet Manufacturing, Corp.<br>P.O. Box 587<br>Warsaw, IN 46581-0587 |
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Tracy J. Bickel Contact Person: Regulatory Associate Biomet Manufacturing Corp. [phone]

Maxim® Accel (Vanguard™) PS+ Bearings Proprietary Name:

Knee bearing (insert) Common Name:

Classification Name: Cemented semi-constrained polymer/metal/polymer knee prosthesis (888.3560)

Substantially Equivalent Devices: Maxim® Accel Knee System - K023546

Device Description: The Maxim® Accel (Vanguard™) PS+ Bearing is intended to replace the articular portions of the knee joint. The system is posterior stabilized (PS) that limits axial and varus/valgus rotation.

#### Intended Use:

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

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

Summary of Technologies: The posterior stabilized bearing features have been modified from its Sunmal y or rechnologies: The postoalgus restraint. The Maxim® Accel (Vanguard™) PS+ onginal sattle to eno warrans, design, sizing, and indications are similar and/or identical to the predicate device. This submission modifies the posterior stabilized bearing features.

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.

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

.

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

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FAX [phone]

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 1 2004

Tracy J. Bickel, RAC Regulatory Associate Biomet Manufacturing Corporation 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581

Re: K041046

Trade/Device Name: Maxim® Accel (Vanguard") PS+ Bearings Regulation Number: 21 CFR 888.3560 Regulation Name: ET OF Resorted comented prosthesis Regulatory Class: II Product Code: JWH Dated: April 21, 2004 Received: April 22, 2004

Dear Ms Bickel:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed your beceined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of the to they 2011a) 2011ance with the provisions of the Federal Food, Drug, devices that have been recise and require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, increasers, misions of the Act include requirements for annual registration, listing of general controls profice, 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 If your device 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 complics with other requirements of the Act than a Dederal statutes and regulations administered by other Federal agencies. You must or uny I 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 - Tracy J. Bickel, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and in your e FDA finding of substantial equivalence of your device to a legally premaince noticated wice 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 If you desire specific darioliance 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 other general 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,

Mark A. Melkerson, Ph.D., M.D.

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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# Indications for Use

## 510(k) Number (if known):

Device Name: Maxim® Accel (Vanguard™) PS+ Bearings

### Indications For Use:

- 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, r and "alsublished one or more compartments are involved.
- 2. Correction of varus, valgus, or posttraumatic deformity.
- 2. Correction or revision of possible of possible of failure of previous joint replacement procedure.

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

| Prescription Use | X | AND/OR | Over-The-Counter Use | |
|-----------------------------|---|--------|------------------------|--|
| (Part 21 CFR 801 Subpart D) | | | (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)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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510(k) Number K041046