MAXIM KNEE SYSTEM

K993159 · Biomet, Inc. · JWH · Oct 14, 1999 · Orthopedic

Device Facts

• Record ID: K993159
• Device Name: MAXIM KNEE SYSTEM
• Applicant: Biomet, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Oct 14, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Maxim Knee System is indicated for: 1) Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, and/or 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. This device is for use with bone cement

Device Story

Maxim Knee System is a semi-constrained, cemented patellofemorotibial prosthesis. Femoral components are Co-Cr-Mo alloy; designed to provide posterior stabilization via a posterior flange interacting with a tibial polyethylene post. Modifications include increased anterior flange height, decreased angle, threaded femoral augment holes, and retinacular relief. Available in six sizes, left and right configurations. Used by orthopedic surgeons in clinical settings for total knee arthroplasty to reconstruct natural femoral kinematics and dimensions. Device is fixed using bone cement. Benefits include pain relief and restoration of joint function in patients with degenerative or traumatic knee conditions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Co-Cr-Mo alloy (ASTM F-75). Design: Semi-constrained, cemented, posterior-stabilized knee prosthesis. Features: Threaded femoral augment holes, retinacular relief, modified anterior flange geometry. Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

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

• Maximum Congruent Knee (K915132)

Submission Summary (Full Text)

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K 9 9 3 1 5 9

OCT 1 4 1999

10/00/ 28 100 / 22

## SUMMARY OF SAFETY AND EFFECTIVENESS

- Sponsor: Biomet Inc. Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0587
4225 UI 4 1100

- Contact Person: Tracy J. Bickel [phone]
Device(s): Maxim Knee System (Maxim PS w/ Retinacular Relief and Maxim PS V-II).

Knee joint patellofemorotibial polymer/metal/polymer semi-Classification: constrained cemented prosthesis (CFR 888.3560)

Device Description: The Maxim Knee femorals are composed of Co-Cr-Mo conforming to ASTM F-75 standards. The posterior stabilized femoral components provide stabilization in knees with soft tissue deficiencies. The devices achieve stability against posterior tibial subluxation through the posterior flange of the femoral component meeting a central polyethylene post on the tibial component. This configuration allows for minimal femoral femoral roll back and rotational instability. The modifications made to the anterior flange were the increase in height and the decrease in angle. The femoral augment holes are now threaded instead of unthreaded and material was removed from the anterior flange in the form of retinaculum relief.

There are six sizes available in both right and left configurations for the Maxim PS V-II femoral components as well as the Maxim PS w/ Retinacular Relief femoral components. The femoral articulation is the same as the Maximum Congruent Knee (K915132). The anatomic component design allows the surgeon to reconstruct the anatomic dimensions and kinematics of the natural femur. The femoral component has an Interlok finish for use in cemented applications.

The Maxim Knee System is indicated for:

- 1) Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, and/or 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.

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Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:

Reaction to bone cement Deformity of the joint Cardiovascular disease Fracture of the cement Implant loosening/migration Tissue growth failure

Blood vessel damage Soft tissue imbalance Delayed wound healing Metal sensitivity Fracture of the components Nerve damage

Bone fracture Infection Hematoma Dislocation Excessive wear

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines beneath them.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 4 1999

Ms. Tracy J. Bickel Regulatory Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana

K993159 Re: Maxim Knee System Requlatory Class: II Product Code: JWH September 20, 1999 Dated: Received: September 21, 1999

## Dear Ms. Bickel:

We have reviewed your Section 510(k) 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 You may, therefore, Food, Drug, and Cosmetic Act (Act). market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Tracy J. Bickel

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director

Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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k913159 510(k) Number (if known): Device Name: Maxim Knee System Indications for Use:

The Maxim Knee System is indicated for:

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

This device is for use with bone cement

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X | OR | Over-The |
|-----------------------------------------|---------|----|------------|
| (Per 21 CFR 801.109) | | | (Optional) |
| (Division Sign-Off) | | | 000007 |
| Division of General Restorative Devices | | | |
| 510(k) Number | K992159 | | |

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