FDA 510(k)

METS SMILES TOTAL KNEE REPLACEMENT

K-Number: K120992 · 2012-09-05

ApplicantStanmore Implants Worldwide , Ltd.

Decision Date2012-09-05

Product CodeKRO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

METS SMILES TOTAL KNEE REPLACEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Stanmore Implants Worldwide , Ltd.. It received FDA 510(k) clearance on 2012-09-05 under 510(k) number K120992. 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 METS SMILES TOTAL KNEE REPLACEMENT?

METS SMILES TOTAL KNEE REPLACEMENT is a medical device that received FDA 510(k) clearance on 2012-09-05. The listed applicant is Stanmore Implants Worldwide , Ltd.. The 510(k) number is K120992.

When did METS SMILES TOTAL KNEE REPLACEMENT receive FDA 510(k) clearance?

METS SMILES TOTAL KNEE REPLACEMENT received FDA 510(k) clearance on 2012-09-05, under 510(k) number K120992.

Who is the listed applicant for METS SMILES TOTAL KNEE REPLACEMENT?

The FDA 510(k) record lists Stanmore Implants Worldwide , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for METS SMILES TOTAL KNEE REPLACEMENT?

The FDA product code for METS SMILES TOTAL KNEE REPLACEMENT is KRO.

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Other records listing Stanmore Implants Worldwide , Ltd. as applicant

K121765SCULPTOR ROBOTIC GUIDANCE ARM (RGA)K121056METS MODULAR PROXIMAL FEMUR K121029METS MODULAR DISTAL FEMUR K121055METS MODULAR TOTAL FEMUR K092138JTS EXTENDEABLE IMPLANT

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.