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Hydroxyapatite (HA) Reflection Acetabular Shell, Hydroxyapatite (HA) Reflection Interfit Shell

by Smith & Nephew, Inc.

510(k) K990666

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 · Abbreviated NumberK990666 Date6 Aug 1999ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2297-2016 FDA Class II initiated 6 Jul 2016

    The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MEH
Device class
Class II
Regulation
21 CFR Part 888.3353
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

This device is a hydroxyapatite-coated acetabular shell designed for hip arthroplasty. It is intended for cementless fixation in semi-constrained hip prostheses.

The device is supplied sterile and is for single use only. It is classified under product code MEH and received FDA 510(k) clearance (K990666) on August 6, 1999, as substantially equivalent to a predicate device.

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