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FDA 510(k)

Restoration® Modular Hip System

K-Number: K212187 · 2022-03-01

ApplicantHowmedica Osteonics Corp., Dba Stryker Orthopaedics
Decision Date2022-03-01
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Restoration® Modular Hip System is a medical device manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2022-03-01 under approval number K212187. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Restoration® Modular Hip System?

Restoration® Modular Hip System is a medical device that received FDA 510(k) clearance on 2022-03-01. It is manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K212187.

When was Restoration® Modular Hip System approved by the FDA?

Restoration® Modular Hip System received FDA 510(k) clearance on 2022-03-01, under approval number K212187.

What company makes Restoration® Modular Hip System?

Restoration® Modular Hip System is manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics.

What is the FDA product code for Restoration® Modular Hip System?

The FDA product code for Restoration® Modular Hip System is LPH.

Related Clinical Trials

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Other Devices by Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K202016Dall-Miles® Cable System K201343Triathlon Total KneeSystem K213129Restoration Modular 115mm Conical Distal Stem K211303Avon Patello-femoral Joint Prosthesis K222632UHR Bipolar Implants, Restoration GAP II Implants K220376Acetabular Dome Hole Plug

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Related Devices (Code: LPH)

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc. K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K161184iNSitu Total Hip SystemTheken Companies, LLC K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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