FDA 510(k)

ENDURO KNEE SYSTEM

K-Number: K101815 · 2010-12-20

Decision Date2010-12-20

Product CodeKRO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ENDURO KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Implant Systems. It received FDA 510(k) clearance on 2010-12-20 under 510(k) number K101815. 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 ENDURO KNEE SYSTEM?

ENDURO KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2010-12-20. The listed applicant is Aesculap Implant Systems. The 510(k) number is K101815.

When did ENDURO KNEE SYSTEM receive FDA 510(k) clearance?

ENDURO KNEE SYSTEM received FDA 510(k) clearance on 2010-12-20, under 510(k) number K101815.

Who is the listed applicant for ENDURO KNEE SYSTEM?

The FDA 510(k) record lists Aesculap Implant Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDURO KNEE SYSTEM?

The FDA product code for ENDURO KNEE SYSTEM is KRO.

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Other records listing Aesculap Implant Systems as applicant

K121879VEGA KNEE SYSTEM K100623AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM K090299BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS K090657MODIFICATION TO: S4 SPINAL SYSTEM K071945S4 SPINAL SYSTEM

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.