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FDA 510(k)

Restoration® Modular Hip System

K-Number: K193233 · 2020-05-27

ApplicantHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)
Decision Date2020-05-27
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Restoration® Modular Hip System is a medical device manufactured by Howmedica Osteonics Corp. (Aka Stryker Orthopaedics). It received FDA 510(k) clearance on 2020-05-27 under approval number K193233. 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 2020-05-27. It is manufactured by Howmedica Osteonics Corp. (Aka Stryker Orthopaedics). The 510(k) number is K193233.

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

Restoration® Modular Hip System received FDA 510(k) clearance on 2020-05-27, under approval number K193233.

What company makes Restoration® Modular Hip System?

Restoration® Modular Hip System is manufactured by Howmedica Osteonics Corp. (Aka 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

NCT07523620 Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration RECRUITING NCT04798768 Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing ACTIVE_NOT_RECRUITING NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED NCT04358601 All-poly Versus Metal-backed ACTIVE_NOT_RECRUITING NCT06672458 Upper Extremity Functional Electrical Stimulation (FES) for Restoration of Upper Extremity Function After Spinal Cord Injury (SCI) RECRUITING NCT03216005 Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System TERMINATED

Other Devices by Howmedica Osteonics Corp. (Aka Stryker Orthopaedics)

K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment

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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