Metal on Metal Acetabular System
FDA 510(k)Class III (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K993438 FDA 510(k)
- FDA Product Code
- KWA FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3330 FDA 510(k)
- Regulation Number
- 888.3330 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Metal on Metal Acetabular System is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component). It is designed as an uncemented acetabular cup for total hip arthroplasty, featuring a cobalt alloy metallic liner articulating against a metal surface to reduce wear and friction in the hip joint.
This system is supplied as a modular titanium outer shell with plasma-sprayed coating for enhanced fixation, paired with a cobalt alloy liner. It is intended for use in orthopedic settings and is classified as a Class III device under FDA regulations. The system includes multiple reference codes (e.g., 3020282716, 1000116912) and is available in various sizes for customizable implantation. Sterility and single-use or reusable status are not specified in the provided data.
Frequently asked questions
What types of hip surgeries is this Metal on Metal Acetabular System designed for, and why is the metal-on-metal articulation significant?
This system is specifically designed for total hip arthroplasty, serving as an uncemented acetabular cup. The metal-on-metal articulation reduces wear and friction in the hip joint, which can be particularly beneficial for patients requiring durable, long-lasting implants, as metal components tend to resist degradation over time compared to other materials.
How is the Metal on Metal Acetabular System constructed, and what materials are used?
The system consists of a modular titanium outer shell with a plasma-sprayed coating to enhance fixation to the bone. It pairs with a cobalt alloy liner, which articulates against another metal surface. The combination of titanium for the shell and cobalt alloy for the liner is intended to provide stability and durability in the hip joint.
Are there multiple sizes available for this device, and how does this affect customization during surgery?
Yes, the Metal on Metal Acetabular System is available in various sizes, allowing for customizable implantation to better fit the anatomical needs of individual patients. This modularity ensures surgeons can select the appropriate dimensions to optimize fit, stability, and function during total hip arthroplasty.
How was this device’s regulatory pathway determined, and what does the classification as a Class III device imply?
The device was determined to be substantially equivalent through a traditional 510(k) clearance process, reviewed by the Orthopedic (OR) Advisory Committee. As a Class III device under FDA regulations, it is classified based on its intended use in surgical procedures where patient safety and efficacy are critical, requiring rigorous premarket approval or clearance to ensure safety and performance.
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: METAL ON METAL ACETABULAR SYSTEM (K993438) — FDA 510 (k) | Innolitics, G7® Acetabular System - Zimmer Biomet | Primary and Revision Hip ..., PDF G2 M M Jv4Z - Food and Drug Administration, Short-term results of the M2a-taper metal-on-metal articulation
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K993438 | Class III | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K993438 24 fields · synced Sep 18, 2026