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FMP Metal/Metal Acetabular Insert, 499-28, 449-34, 499-38

FDA 510(k)

Class III (US FDA 510(k))

510(k) K070221

by Encore Medical L.P.

Identifiers

510(k) Number
K070221 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 FMP Metal/Metal Acetabular Insert is a semi-constrained, uncemented acetabular component for hip prostheses, designed to replace the natural acetabulum in total hip arthroplasty. Constructed from metal, it is intended to articulate with a femoral component to restore hip joint function, addressing conditions such as degenerative disease, arthritis, deformity, or fracture.

Implanted by orthopedic surgeons in clinical or hospital settings, these inserts are supplied sterile and intended for single-use. The device is classified as Class III under FDA regulations (product code KWA) and has received FDA 510(k) clearance through the Traditional pathway. Available in specified model numbers (499-28, 449-34, 499-38), it adheres to regulatory standards for orthopedic hip prostheses.

Frequently asked questions

What clinical conditions is this acetabular insert designed to address in total hip arthroplasty?

The FMP Metal/Metal Acetabular Insert is specifically designed to replace the natural acetabulum in total hip arthroplasty for patients suffering from degenerative disease, arthritis, deformity, or fracture. It is intended to restore hip joint function by articulating with a femoral component, providing a stable alternative to the damaged or diseased natural joint.

How is the FMP Metal/Metal Acetabular Insert supplied, and is it intended for single-use or reuse?

The FMP Metal/Metal Acetabular Insert is supplied sterile and is explicitly intended for single-use only. This ensures patient safety and reduces the risk of cross-contamination or infection, aligning with standard orthopedic implant practices.

What are the available model numbers for this device, and how do they differ?

The FMP Metal/Metal Acetabular Insert is available in three model numbers: 499-28, 449-34, and 499-38. While the exact differences between these models (e.g., size, geometry, or constraints) are not detailed in the provided data, these variations likely cater to different patient anatomies or surgical preferences. For precise sizing or application guidance, refer to Encore Medical’s technical documentation or surgical planning tools.

What regulatory pathway was used for FDA clearance of this device, and what does that mean for its safety and performance?

The FMP Metal/Metal Acetabular Insert received FDA 510(k) clearance through the Traditional pathway, with a determination of Substantially Equivalent (SESE) to a predicate device. This means the FDA reviewed it against a previously cleared or approved hip prosthesis and concluded it has the same intended use and technological characteristics, ensuring it meets applicable safety and effectiveness standards for orthopedic implants.

Where is this device manufactured, and how should it be stored to maintain sterility?

While the manufacturer’s address (Encore Medical L.P., Austin, TX 78758) is provided, storage instructions for sterility are not explicitly detailed in the data. Generally, sterile medical devices like this should be stored in a clean, dry environment away from direct sunlight or extreme temperatures until use. Always follow the manufacturer’s specific storage guidelines included in the packaging or accompanying documentation to preserve sterility and integrity.

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: Fmp Metal/Metal Acetabular Insert, 499-28,449-34, 499-38, FMP METAL/METAL ACETABULAR INSERT (K003250) — FDA 510 (k) | Innolitics, K003250 - FMP METAL/METAL ACETABULAR INSERT | FDA 510 (k), Modification To: Fmp Metal/Metal Acetabular Insert, Models 499-28, 499 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Encore Medical L.P.

Sources (1)

  • FDA 510(k) K070221 24 fields · synced Sep 18, 2026