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MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT - 499-38

FDA 510(k)

Class III (US FDA 510(k))

510(k) K063414

by Encore Medical L.P.

Identifiers

510(k) Number
K063414 FDA 510(k)
FDA Product Code
KWA FDA 510(k)
Models / Variants
499-28 FDA 510(k)
499-34 FDA 510(k)
499-38 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)

This device is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component), designed as a metal-on-metal acetabular insert for use in total hip arthroplasty. It is intended to replace the damaged femoral head and acetabulum, providing a stable, low-friction articulation to restore hip function and alleviate pain.

The FMP Metal/Metal Acetabular Insert is supplied sterile and intended for single-use in orthopedic surgical settings. Available in three models (499-28, 499-34, 499-38), it is classified as a Class III device under FDA regulations and has received 510(k) clearance through a Special Advisory Committee review. Compliance with MRI safety standards and proper storage conditions are required to maintain device integrity.

Frequently asked questions

What are the key differences between the three models (499-28, 499-34, 499-38) of this acetabular insert, and how might a surgeon choose between them?

The three models (499-28, 499-34, 499-38) of the FMP Metal/Metal Acetabular Insert are designed for different acetabular sizes or patient anatomies, though the exact dimensions are not specified in the data. Surgeons typically select the model based on the patient’s pelvic anatomy, acetabular cavity size, and the desired range of motion or stability for the hip joint. The numerical differences likely correspond to variations in diameter or cup depth, allowing for customization to fit individual patients during total hip arthroplasty.

Is this device compatible with MRI scans, and if so, what precautions should be taken during imaging?

Yes, the FMP Metal/Metal Acetabular Insert is designed with compliance to MRI safety standards in mind, though specific MRI-safe protocols (e.g., field strength limits or imaging sequences) are not detailed in the data. Clinicians should follow the manufacturer’s guidelines for MRI safety, including verifying compatibility with the imaging facility’s equipment and adhering to recommended scan parameters to avoid artifacts or potential risks associated with metal implants.

How should this device be stored to maintain its sterility and integrity before use?

The FMP Metal/Metal Acetabular Insert is supplied sterile, so it must be stored in its original packaging under controlled conditions to preserve sterility and prevent contamination. The data does not specify exact storage requirements, but standard practices for orthopedic implants—such as keeping the device in a clean, dry environment away from direct sunlight, extreme temperatures, or moisture—should be followed. Always check the packaging for expiration dates or storage instructions provided by the manufacturer.

Can this acetabular insert be reused in multiple surgeries, or is it intended for single-use only?

This device is explicitly intended for single-use in orthopedic surgical settings, as stated in the description. Reusing it could compromise sterility, integrity, or patient safety, particularly for metal-on-metal components where wear or contamination risks are heightened. Single-use ensures compliance with best practices for infection control and device performance.

What regulatory pathway was followed for this device’s clearance, and how does that affect its use in clinical practice?

The FMP Metal/Metal Acetabular Insert received FDA 510(k) clearance through a Special Advisory Committee review (Orthopedic Panel) under the Substantially Equivalent determination. This means the device was deemed comparable to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for semi-constrained metal acetabular components. Clinicians can rely on this clearance as evidence of regulatory scrutiny, though individual hospitals may have additional procurement or surgical protocol requirements.

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.

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) K063414 24 fields · synced Sep 18, 2026