Maxim Removable Molded Poly Tibia
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K991753 FDA 510(k)
- FDA Product Code
- JWH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3560 FDA 510(k)
- Regulation Number
- 888.3560 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Maxim Removable Molded Poly Tibia is a removable tibial component for total knee arthroplasty, classified as a tibial plateau prosthesis (UHD—Hinge Knee Prosthesis, Tibial Component). It features a cobalt-chromium (CoCr) tibial plate with a removable ultra-high-molecular-weight polyethylene (UHMWPE) tibial bearing, designed to replace the articulating surface of the tibia during knee replacement surgery.
Implanted in clinical or hospital settings by orthopedic surgeons, this device is intended for use with previously cleared Maxim femoral components (K915132). Supplied sterile and intended for single-use, it adheres to FDA 510(k) clearance (K991753) under the Orthopedic advisory committee. No additional regulatory status or MRI safety information is specified.
Frequently asked questions
What is the Maxim Removable Molded Poly Tibia used for in knee replacement surgery?
The Maxim Removable Molded Poly Tibia is designed as a removable tibial component for total knee arthroplasty, specifically to replace the articulating surface of the tibia. It pairs with previously cleared Maxim femoral components (K915132) to restore knee function by providing a smooth, polyethylene-bearing surface that articulates with the femur. It is intended for use in clinical or hospital settings by orthopedic surgeons during knee replacement procedures.
Is this device single-use or reusable, and how is it supplied?
The Maxim Removable Molded Poly Tibia is supplied sterile and explicitly intended for single-use only. It comes pre-packaged for surgical use, ensuring sterility and minimizing the risk of contamination or cross-infection between patients. Reuse is not recommended or supported by the manufacturer.
What materials are used in the construction of the Maxim Removable Molded Poly Tibia?
The device features a cobalt-chromium (CoCr) tibial plate as its base structure, which provides durability and strength. The articulating surface is a removable ultra-high-molecular-weight polyethylene (UHMWPE) tibial bearing, designed to reduce friction and wear during knee movement. This combination ensures long-term stability and smooth joint function.
How was the FDA clearance for this device determined, and which advisory committee reviewed it?
The Maxim Removable Molded Poly Tibia received FDA clearance under the 510(k) pathway, specifically classified as substantially equivalent (SESE) to a predicate device. The review was conducted by the Orthopedic (OR) Advisory Committee, which evaluates orthopedic implants like tibial plateau prostheses. The clearance (K991753) was granted in 1999 after submission to the FDA’s Orthopedic division.
What should I consider when storing this device before use?
Since the device is supplied sterile and intended for single-use, it should be stored in its original, unopened packaging to preserve sterility. The packaging should be kept in a clean, dry environment away from direct sunlight, extreme temperatures, or contaminants. Always check the expiration date on the packaging before use to ensure the device remains within its specified shelf life.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MAXIM REMOVABLE MOLDED POLY TIBIA - Innolitics, MAXIM REMOVABLE MOLDED POLY TIBIA (K984623) — FDA 510(k) | Innolitics, MAXIM REMOVABLE MOLDED POLY TIBIA 510(k) K991753 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K991753 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K991753 24 fields · synced Sep 19, 2026