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Metal Backed Acetabular Component (JDL)

by Encore Orthopedics, Inc.

510(k) K950542

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK950542 Date25 May 1995ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0799-06 FDA Unclassified (pre-2012) initiated 12 Jan 2006 on shared 510(k) K950542

    Voids in the porous coating of a component used in total hip replacement surgery.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Metal Backed Acetabular Component
510(k) Number
FDA Product Code
JDL
Device Class
Class III
Regulation
21 CFR Part 888.3320
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Metal Backed Acetabular Component is a Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) designed for use in total hip arthroplasty. This device features a metal shell integrated with a polyethylene or ceramic liner, providing structural support and articulation for the femoral head within the pelvis. It is intended to restore hip joint function by replacing the damaged acetabulum with a durable, load-bearing surface.

This device is supplied as a reusable surgical implant, intended for use in orthopedic procedures under sterile conditions. It is classified as a Class III medical device under FDA regulations and has received FDA 510(k) clearance (K950542, K963998) for substantial equivalence to predicate devices. Multiple sizes and variants are available, as referenced by the listed FEI numbers, and it is regulated under 21 CFR 888.3320. Testing includes liner attachment strength to ensure fixation integrity.

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