FDA 510(k)

Modular Rotating Hinge Knee Systems and Compatible Components

K-Number: K223069 · 2023-04-21

ApplicantHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Decision Date2023-04-21

Product CodeKRO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Modular Rotating Hinge Knee Systems and Compatible Components is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2023-04-21 under 510(k) number K223069. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Modular Rotating Hinge Knee Systems and Compatible Components?

Modular Rotating Hinge Knee Systems and Compatible Components is a medical device that received FDA 510(k) clearance on 2023-04-21. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K223069.

When did Modular Rotating Hinge Knee Systems and Compatible Components receive FDA 510(k) clearance?

Modular Rotating Hinge Knee Systems and Compatible Components received FDA 510(k) clearance on 2023-04-21, under 510(k) number K223069.

Who is the listed applicant for Modular Rotating Hinge Knee Systems and Compatible Components?

The FDA 510(k) record lists Howmedica Osteonics Corp., Dba Stryker Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Modular Rotating Hinge Knee Systems and Compatible Components?

The FDA product code for Modular Rotating Hinge Knee Systems and Compatible Components is KRO.

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Other records listing Howmedica Osteonics Corp., Dba Stryker Orthopaedics as applicant

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Related Devices (Code: KRO)

K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge BumperHowmedica Osteonics Corp., Dba Stryker Orthopaedics K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics K242871ATTUNE™ Revision Hinge KneeDepuy Ireland UC K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial InseMicroport Orthopedics, 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.