510(k) K120992 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
METS SMILES TOTAL KNEE REPLACEMENT
| Applicant | Stanmore Implants Worldwide , Ltd., Canton MA, US |
| Decision | Substantially Equivalent, Sep 5, 2012 |
| Received | Apr 2, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120992
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2016 | Stanmore 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 |
KRO | None listed |
| Dec 19, 2016 | Stanmore 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 |
KRO | None listed |
| Dec 19, 2016 | Stanmore 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 |
KRO | None listed |
| Dec 19, 2016 | Stanmore 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 |
KRO | None listed |
| Dec 19, 2016 | Stanmore 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 |
KRO | None listed |
| Aug 17, 2016 | Stanmore Implants Worldwide Ltd. METS SMILES Total Knee Replacement Terminated |
KRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.