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Reflection Acetabular Component

by Smith & Nephew Richards, Inc. 510(k)

Active United States

510(k) K932755

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK932755 Date6 May 1994ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LPH
Device Class
Class II
Regulation
21 CFR Part 888.3358
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Reflection Acetabular Component is an orthopedic device used in hip joint replacement procedures. It is designed to replace the acetabular socket in the pelvis during primary or revision hip arthroplasty.

This device is supplied as a single-use implant and is indicated for use in patients undergoing hip surgery where prior treatments have failed due to trauma or degenerative joint disease. It is authorized under FDA 510(k) clearance K932755 and is intended for use with compatible femoral stems such as the Synergy or Spectron EF systems.

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Questions

AI-generated answers, 21 Sep 2026

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

  • What is the Reflection Acetabular Component used for?

    The Reflection Acetabular Component is used to replace the acetabular socket in the pelvis during hip joint replacement procedures, indicated for patients undergoing primary or revision hip arthroplasty when prior treatments have failed due to trauma or degenerative joint disease.

  • Is the Reflection Acetabular Component supplied as a single-use or reusable device?

    The Reflection Acetabular Component is supplied as a single-use implant, meaning it is intended for one-time use during surgery and should not be reprocessed or reused after implantation to ensure patient safety and device integrity.

  • Which femoral stem systems is the Reflection Acetabular Component compatible with?

    The Reflection Acetabular Component is intended for use with compatible femoral stems such as the Synergy or Spectron EF systems, as specified in its labeling, to ensure proper articulation and biomechanical function in hip replacement procedures.