MAXIM ACCEL KNEE SYSTEM

K023546 · Biomet, Inc. · JWH · Jan 17, 2003 · Orthopedic

Device Facts

• Record ID: K023546
• Device Name: MAXIM ACCEL KNEE SYSTEM
• Applicant: Biomet, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Jan 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 a single use implant intended for implantation with bone cement.

Device Story

Maxim Accel Knee System is a cemented, semi-constrained total knee prosthesis; replaces articular portions of knee joint. System comprises three femoral components with augmentation pieces and three modular tibial bearings. Intended for surgical implantation by orthopedic surgeons in clinical settings. Device functions as mechanical replacement for damaged knee joint surfaces; restores joint function and corrects deformities. Benefits include pain relief and improved mobility for patients with degenerative or traumatic joint conditions. Single-use implant; requires bone cement for fixation.

Clinical Evidence

No clinical data provided as a basis for substantial equivalence. Bench testing performed in accordance with 1994-Draft guidance for cemented, semi-constrained total knee prostheses.

Technological Characteristics

Cemented, semi-constrained polymer/metal/polymer knee prosthesis (Product Code: JWH). System includes femoral components with augmentation and modular tibial bearings. Mechanical testing conducted per 1994-Draft guidance for cemented, semi-constrained total knee prostheses.

Indications for Use

Indicated for patients with painful/disabled knee joints due to osteoarthritis, rheumatoid arthritis, or traumatic arthritis (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

• MCK (K915132)
• Performance (K936274)

Submission Summary (Full Text)

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0225546
BIOMET

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## SUMMARY OF SAFETY AND EFFECTIVENESS

| Sponsor: | Biomet Inc.<br>Airport Industrial Park<br>P.O. Box 587<br>Warsaw, IN 46581-0587<br><br>JAN 17 2003 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tracy J. Bickel<br>[phone] |
| Device(s): | Maxim Accel Knee System |
| Classification Name: | Cemented semi-constrained polymer/metal/polymer (888.3560) |
| Device Classification: | Class II |
| Device Product Code: | 87 JWH |
| Substantially Equivalent Devices: | MCK (K915132); Performance (K936274) |
| Device Description: | The Maxim Accel Knee System is intended to replace the articular portions of the knee<br>joint. The system consists of three femoral components with augmentation pieces and<br>three modular tibial bearings. |

## Indications for Use:

- 1) Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis, 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 replacement 3) procedure.

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

| Summary of Technologies: | The femoral component and tibial bearings have been redesigned.<br>The Maxim Accel Knee System is similar to or identical in terms of function,<br>labeling, and sizing to the predicate MCK device(s). |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-Clinical Testing: | The Maxim Accel Knee System is intended to replace the articular portions of the knee<br>joint. The system consists of three femoral components with augmentation pieces and<br>three modular tibial bearings. All mechanical testing was done in accordance to 1994-<br>Draft guidance for the preparation of Premarket Notifications (510(j)s) for cemented,<br>semi-constrained total knee prostheses. |
| 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

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SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

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OFFICE 574.267.6639

FAX [phone]

E-MAIL [e-mail]

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2003

Ms. Tracy Bickel Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0578

Re: K023546

Trade/Device Name: Maxim Accel Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: October 18, 2002 Received: October 22, 2002

Dear Ms. Bickel:

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 - Ms. Tracy Bickel

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/dsma/dsmamain.html

Sincerely yours,

Mark McMillan

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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K023546

510(k) Number (if known): Device Name: Maxim Accel Knee System Indications for Use:

- 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 a single use implant intended for implantation with bone cement.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milham

ivision Sign-Division of General, Restorative and Neurological Devi

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10(k) Number K023546
K023546