Porous Coated Acetabular Components
FDA 510(k)Class III (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K050124 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 Porous Coated Acetabular Components are semi-constrained, uncemented acetabular prosthesis designed for total hip replacement. These metallic, full-hemisphere acetabular shells are intended to restore hip joint function by providing structural support and stability in the pelvic region. They are engineered to integrate with modular polyethylene liners and taper-fitted femoral head components, facilitating proper articulation and movement.
Implanted in clinical or operating room settings by orthopedic surgeons, these components are used to address degenerative joint diseases, hip fractures, and revision surgeries. Supplied as single-use devices, they are regulated under FDA 510(k) clearance (K050124) and fall under Class III medical device classification. Multiple reference codes (e.g., 3020282716, 1047843) identify distinct variants, ensuring compatibility with various patient anatomies and surgical needs.
Frequently asked questions
Are these acetabular components designed for use in primary hip replacements or primarily for revision surgeries?
The Porous Coated Acetabular Components are intended for both primary total hip replacements and revision surgeries. The device description explicitly mentions use in degenerative joint diseases, hip fractures, and revision surgeries, indicating versatility across these clinical scenarios.
How are these acetabular components supplied, and are they reusable or single-use?
These components are supplied as single-use devices, as stated in the description. They are not intended for reuse and are designed for implantation in clinical or operating room settings by orthopedic surgeons.
What types of modular components are compatible with these acetabular shells?
The Porous Coated Acetabular Components are engineered to integrate with modular polyethylene liners and taper-fitted femoral head components. This modularity ensures proper articulation and movement, accommodating various patient anatomies and surgical needs.
How do I determine the correct size or variant for a specific patient?
The device includes multiple reference codes (e.g., 3020282716, 1047843) that identify distinct variants. These variants are designed to ensure compatibility with different patient anatomies and surgical requirements, so consulting the manufacturer’s sizing guides or catalog will help select the appropriate size.
What regulatory pathway was followed for FDA clearance of these acetabular components?
The Porous Coated Acetabular Components received FDA clearance through a 510(k) submission, classified as Traditional with a Substantially Equivalent determination. The device falls under the Orthopedic advisory committee (OR) and is categorized as a Class III medical device, reflecting its critical role in hip replacement surgeries.
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: POROUS COATED ACETABULAR COMPONENTS - Innolitics, Biomed Prosthetic Devices for Total Hip Replacement, G7® Acetabular System - Zimmer Biomet | Primary and Revision Hip ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050124 | Class III | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K050124 24 fields · synced Sep 20, 2026