Atlas FDA

METS SMILES TOTAL KNEE REPLACEMENT

FDA 510(k) clearance K120992 · decided 2012-09-05

Clearance details

K-number
K120992
Device name
METS SMILES TOTAL KNEE REPLACEMENT
Applicant
Stanmore Implants Worldwide , Ltd.
Decision
Substantially Equivalent
Date received
2012-04-02
Decision date
2012-09-05
Days to decision
156 days
Clearance type
Traditional
Product code
KRO
Device class
2
Regulation number
888.3510
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Canton, MA, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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ATTUNE™ Revision Hinge Knee (K242871)Depuy Ireland UC2024-11-21
EVOLUTION® 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 Inse (K240043)Microport Orthopedics, Inc.2024-04-01
ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System (K233980)Depuy Ireland UC2024-03-21
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Recalls involving this device

RecordFirmDate
Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short The prod recall (Z-0820-2017)Stanmore Implants Worldwide Ltd.2016-12-19
Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial recall (Z-0821-2017)Stanmore Implants Worldwide Ltd.2016-12-19
Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The product is a compo recall (Z-0822-2017)Stanmore Implants Worldwide Ltd.2016-12-19
Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coat recall (Z-0823-2017)Stanmore Implants Worldwide Ltd.2016-12-19
DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coa recall (Z-0824-2017)Stanmore Implants Worldwide Ltd.2016-12-19
METS SMILES Total Knee Replacement recall (Z-2553-2016)Stanmore Implants Worldwide Ltd.2016-08-17