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Metal/Metal Hip System

FDA 510(k)

Class III (US FDA 510(k))

510(k) K040354

by Encore Medical L.P.

Identifiers

510(k) Number
K040354 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)

This device is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) designed for total hip arthroplasty. It features a metal-on-metal bearing surface, intended to replace damaged or diseased hip joints by restoring function and mobility through a durable, low-friction articulation.

The system is supplied as a reusable orthopedic implant, intended for surgical use in controlled clinical settings. Components include acetabular cups with varying sizes (e.g., 34mm Neutral MP7) and are regulated under FDA 510(k) clearance (K040354) as a Class III device under regulation 888.3330. Sterility and MRI safety are not specified in the data, but adherence to orthopedic surgical protocols is required for proper implantation.

Frequently asked questions

What types of hip joint issues is this metal-on-metal hip system designed to address in patients?

This semi-constrained metal-on-metal hip system is specifically designed for total hip arthroplasty to replace damaged or diseased hip joints. It is intended to restore function and mobility by providing a durable, low-friction articulation, making it suitable for patients with severe joint degradation, arthritis, fractures, or other conditions causing significant hip dysfunction.

How is this device supplied, and what sizes are available for surgical use?

The device is supplied as a reusable orthopedic implant for surgical use in controlled clinical settings. It includes acetabular cups in various sizes, such as the 34mm Neutral MP7, among other configurations. The exact sizing options are listed in the provided FEI numbers, but the key detail is that it offers multiple acetabular cup sizes to accommodate different patient anatomies during total hip replacement.

Is this device intended for single-use or can it be reused in multiple procedures?

The device is explicitly described as a reusable orthopedic implant, meaning it is designed for use in multiple surgical procedures after proper sterilization and maintenance. However, adherence to orthopedic surgical protocols is required to ensure safe reuse, as no specific sterilization or MRI safety details are provided in the data.

What regulatory pathway was followed for this hip system’s approval, and how does that affect its use?

This device was cleared through the FDA 510(k) pathway, specifically under K040354, as a Class III device regulated under 21 CFR 888.3330. The clearance was granted via a Special 510(k) determination, meaning it was deemed substantially equivalent to a legally marketed predicate device. Clinicians and buyers should confirm compliance with FDA and institutional protocols when using it in surgical settings.

Are there any special considerations for storage or handling of this metal-on-metal hip system before surgery?

While the data does not specify sterilization methods or MRI safety, the device is intended for controlled clinical settings, implying it must be stored and handled according to standard orthopedic surgical protocols. This includes maintaining a clean, sterile environment and following manufacturer guidelines for preparation to ensure safety and functionality before use.

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/metal Hip System 510 (k) FDA Premarket Notification K040354 ..., MAUDE Adverse Event Report: ENCORE MEDICAL L.P. METAL/METAL HIP SYSTEM ..., PDF K040354 METAL/METAL HIP SYSTEM - 510kdatabase.net, 510(k) Premarket Notification, ENCORE MEDICAL, L.P. FDA Filings - FDA.report

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) K040354 24 fields · synced Sep 18, 2026