Mallory-Head Total Hip System
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K921181 FDA 510(k)
- FDA Product Code
- LZO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3353 FDA 510(k)
- Regulation Number
- 888.3353 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Mallory-Head Total Hip System is a semi-constrained hip prosthesis designed to restore joint function and alleviate pain associated with degenerative or traumatic hip conditions. It consists of metal and polymer components, including femoral components that are geometrically identical to previously cleared designs.
This system is authorized for use under FDA 510(k) clearance. It is categorized as a Class II orthopedic device intended for clinical application in hip replacement procedures.
Frequently asked questions
What is the primary purpose of the Mallory-Head Total Hip System?
This system is a semi-constrained hip prosthesis intended for use in hip replacement procedures. It is designed to restore joint function and provide relief from pain associated with degenerative or traumatic hip conditions.
What materials are used in the construction of this hip system?
The Mallory-Head Total Hip System is composed of both metal and polymer components. These materials are utilized to create a durable prosthesis that functions as a replacement for the natural hip joint.
What is the regulatory status of the Mallory-Head Total Hip System?
The device is authorized for clinical use under FDA 510(k) clearance. It is classified as a Class II orthopedic device, having been determined to be substantially equivalent to previously cleared designs.
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: Mallory/Head Total Hip System; Ha Mallory/Head Total Hip System; Bi ..., MALLORY/HEAD TOTAL HIP SYSTEM (K030055) - FDA 510(k), K853259 - MALLORY/HEAD TOTAL HIP SYSTEM | FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K921181 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K921181 24 fields · synced Sep 26, 2026