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Reflection Ceramic Acetabular System

by Smith & Nephew, Inc.

PMA P030022510(k) K211176

Active United States

PMA, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K211176; other models may be affected

Documents

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK211176 Date1 Jul 2022ClearedStatusActive
United StatesFDA PMA PMA NumberP030022 Date17 Dec 2004ApprovedStatusWithdrawn

Recalls

7 recalls · 1 ongoing · FDA

    • Ongoing Z-0326-2025 FDA Class II initiated 15 Oct 2024 on shared 510(k) K211176

    The Bipolar assembly contains an oversized Retainer Ring.

  • 6 recalls, same reason

    • Terminated Z-2056-2011 FDA Unclassified (pre-2012) initiated 11 Mar 2011 on shared PMA P030022
    • Terminated Z-2054-2011 FDA Unclassified (pre-2012) initiated 11 Mar 2011 on shared PMA P030022
    • Terminated Z-2058-2011 FDA Unclassified (pre-2012) initiated 11 Mar 2011 on shared PMA P030022
    • Terminated Z-2055-2011 FDA Unclassified (pre-2012) initiated 11 Mar 2011 on shared PMA P030022
    • Terminated Z-2053-2011 FDA Unclassified (pre-2012) initiated 11 Mar 2011 on shared PMA P030022
    • Terminated Z-2057-2011 FDA Unclassified (pre-2012) initiated 11 Mar 2011 on shared PMA P030022

    During the manufacturing process for several batches of R3 Ceramic Liners, the titanium rings were pressed onto the ceramic component with a higher force than allowed by manufacturing specifications. This has the potential to result in lower than expected strength for the liners.

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  • Withdrawn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), FDA PMA Active

Specification

510(k) · PMA

Full name
Reflection Ceramic Hip System
Trade name
Reflection Ceramic Acetabular System
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
PMA number
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, 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 Reflection Ceramic Acetabular System is a semi-constrained hip prosthesis designed for use in total hip arthroplasty. It is indicated for patients requiring primary hip replacement due to non-inflammatory arthritis, including osteoarthritis, avascular necrosis, or traumatic arthritis.

This system is manufactured by Smith & Nephew and is available for both cemented and uncemented applications. It is regulated as a medical device under FDA 510(k) and PMA authorizations. The device is intended for clinical use in orthopedic surgical settings.

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Questions

AI-generated answers, 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.

  • What is the Reflection Ceramic Acetabular System used for?

    This device is indicated for use in patients undergoing primary total hip arthroplasty to treat non-inflammatory arthritis, such as osteoarthritis, avascular necrosis, or traumatic arthritis.

  • Is this hip system cemented or uncemented?

    The Reflection Ceramic Acetabular System is designed to be compatible with both cemented and uncemented surgical techniques, providing flexibility for the orthopedic surgeon.

  • What type of device is the Reflection Ceramic Acetabular System?

    It is classified as a semi-constrained hip prosthesis featuring metal and ceramic components, designed to replace the hip joint during arthroplasty procedures.