ClearanceBrief
Company ยท US

Stanmore Implants Worldwide , Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2015. Name variants (Inc, Corp, punctuation) are merged.

8510(k) clearances (0 in 12 months)
8recalls (0 in 12 months)
7recalls that name a 510(k)

Product codes

CodeDeviceRecords
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer12
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1
OLOOrthopedic Stereotaxic Instrument1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jan 20, 2015K140898PATIENT SPECIFIC DISTAL FEMORAL
Stanmore Implants Worldwide , Ltd.
KRO
Jan 22, 2014K133152JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
Stanmore Implants Worldwide , Ltd.
KRO
Jan 11, 2013K121765SCULPTOR ROBOTIC GUIDANCE ARM (RGA)
Stanmore Implants Worldwide , Ltd.
OLO
Sep 20, 2012K121056METS MODULAR PROXIMAL FEMUR
Stanmore Implants Worldwide , Ltd.
JDI
Sep 19, 2012K121055METS MODULAR TOTAL FEMUR
Stanmore Implants Worldwide , Ltd.
JDI
Sep 19, 2012K121029METS MODULAR DISTAL FEMUR
Stanmore Implants Worldwide , Ltd.
KRO
Sep 5, 2012K120992METS SMILES TOTAL KNEE REPLACEMENT
Stanmore Implants Worldwide , Ltd.
KRO
Mar 22, 2011K092138JTS EXTENDEABLE IMPLANT
Stanmore Implants Worldwide , Ltd.
KRO

Latest recalls

DateFirm and productCodeLinked 510(k)
Jul 4, 2017Stanmore Implants Worldwide Ltd.
JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.
Terminated		 KROK092138
K133152 +1
Dec 19, 2016Stanmore Implants Worldwide Ltd.
DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF Coated Integral Shaft & Stem 30x36x44 The product is a com
Terminated		 KROK120992
Dec 19, 2016Stanmore Implants Worldwide Ltd.
Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Femoral Integral Shaft & Stem 30x27 HA Coated; Femoral Integral Shaft & Stem 30x30 HA Coated The p
Terminated		 KROK120992
Dec 19, 2016Stanmore Implants Worldwide Ltd.
Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, di
Terminated		 KROK120992
Dec 19, 2016Stanmore Implants Worldwide Ltd.
Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Cased Std Short The product is a component is a systems
Terminated		 KROK120992
Dec 19, 2016Stanmore Implants Worldwide Ltd.
Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the
Terminated		 KROK120992
Aug 17, 2016Stanmore Implants Worldwide Ltd.
METS SMILES Total Knee Replacement
Terminated		 KROK120992
May 9, 2016Stanmore Implants Worldwide Ltd.
Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
Terminated		 JWHNone listed
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