FDA 510(k)

HINGED KNEE

K-Number: K982160 · 1999-03-17

Decision Date1999-03-17

Product CodeKRO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

HINGED KNEE is the device name listed in this FDA 510(k) record. The listed applicant is Encore Orthopedics, Inc.. It received FDA 510(k) clearance on 1999-03-17 under 510(k) number K982160. 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 HINGED KNEE?

HINGED KNEE is a medical device that received FDA 510(k) clearance on 1999-03-17. The listed applicant is Encore Orthopedics, Inc.. The 510(k) number is K982160.

When did HINGED KNEE receive FDA 510(k) clearance?

HINGED KNEE received FDA 510(k) clearance on 1999-03-17, under 510(k) number K982160.

Who is the listed applicant for HINGED KNEE?

The FDA 510(k) record lists Encore Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HINGED KNEE?

The FDA product code for HINGED KNEE is KRO.

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Other records listing Encore Orthopedics, Inc. as applicant

K0329053DKNEE POROUS COATED FEMORAL COMPONENT K0201143D KNEE K020741UNICONDYLAR KNEE K020236MODIFICATION TO PASS SPINAL SYSTEM K020170KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP K013490CEMENTED CALCAR HIP SYSTEM

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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

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