MAXIM REMOVABLE MOLDED POLY TIBIA

K991753 · Biomet, Inc. · JWH · Aug 17, 1999 · Orthopedic

Device Facts

• Record ID: K991753
• Device Name: MAXIM REMOVABLE MOLDED POLY TIBIA
• Applicant: Biomet, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Aug 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indications for use of knee joint replacement prostheses include: 1) painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved, 2) failure of a previous joint replacement procedure, 3) correction of varus, valgus, or post traumatic deformity, and 4) correction or revision of unsuccessful osteotomy or arthrodesis. The device is a single use implant and is intended for cemented application only.

Device Story

Maxim Removable Molded Poly Tibia is a cemented knee joint prosthesis component; replaces tibial articulating surface in total knee arthroplasty. Device consists of CoCr tibial plate with removable molded UHMWPE tibial bearing; designed for use with previously cleared Maxim femoral components (K915132). Implanted by orthopedic surgeons in clinical/hospital settings during total knee replacement surgery. Provides stable articulating surface to restore joint function; reduces pain; corrects deformities. Single-use implant.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Cobalt-Chromium (CoCr) tibial plate, Ultra-High Molecular Weight Polyethylene (UHMWPE) tibial bearing. Design: Semi-constrained, cemented, modular tibial component. Single-use.

Indications for Use

Indicated for patients with painful/disabled knee joints due to osteoarthritis, rheumatoid arthritis, or traumatic arthritis (single or multi-compartment); patients requiring revision of failed joint replacement, correction of varus/valgus/post-traumatic deformity, or correction of unsuccessful osteotomy/arthrodesis.

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).

Reference Devices

• Maxim femoral components (K915132)

Submission Summary (Full Text)

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AUG 17 1999

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## K991753

## SUMMARY OF SAFETY AND EFFECTIVENESS

Sponsor: Biomet, Inc. Airport Industrial Park Warsaw, Indiana 46580

Device: Biomet

Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis

Intended Use: Indications for use of knee joint replacement prostheses include: 1) painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved, 2) failure of a previous joint replacement procedure, 3) correction of varus, valgus, or post traumatic deformity, and 4) correction or revision of unsuccessful osteotomy or arthrodesis. The device is a single use implant and is intended for cemented application only.

Device Description: The Maxim Removable Molded Poly Tibia is intended to replace the tibial articulating surface in a total joint replacement with Maxim femoral components cleared in 510(k) K915132. This device is a CoCr tibial plate with a removable molded UHMWPE tibial bearing that can be used with previously cleared modular Maxim tibial bearings.

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 Fracture of the components Cardiovascular disorders Implant loosening/migration Soft tissue imbalance Deformity of the joint Delayed wound healing Fracture of the cement Dislocation

- Bone fracture Hematoma Blood vessel damage Nerve damage Excessive wear Infection Metal sensitivity Breakdown of porous surface
Substantial Equivalence: In function and overall design the Maxim Removable Molded Poly Tibia Prosthesis is equivalent to other commercially available tibial components currently on the market.

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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of a stylized eagle with three lines representing its wings and body. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 17 1999

Mr. Fred McClure Regulatory Specialist Biomet Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K991753

Trade Name: Maxim Removable Molded Poly Tibia Regulatory Class: II Product Code: JWH Dated: May 20, 1999 Received: May 24, 1999

Dear Mr. McClure:

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 Food, Drug, and Cosmetic Act (Act). 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 (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 regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation vou 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- Mr. Fred McClure

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 regulation (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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Nursell Ingram

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

Enclosure

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## 510 (k) Number (if known) : _ K991753

Line Extension of the Maxim Removable Molded Poly Tibia Device Name:

Indications for use of knee joint replacement prostheses include: 1) painful and Indications For Use: disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved, 2) failure of a previous joint replacement procedure, 3) correction of varus, valgus, or post traumatic deformity, and 4) correction of unsuccessful osteotomy or arthrodesis. The device is a single use implant intended for use with bone cement.

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Division S

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Prescription Use
(Per 21 CFR 801.109)

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