510(k) K122277 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 22, 2012 |
| Received | Jul 30, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122277
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2013 | Biomet, Inc. REF 154200 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size A3 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154201 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size A4 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154202 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size A5 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154203 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size A6 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154204 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size A7 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154207 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size B3 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154208 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size B4 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154209 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size B5 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154210 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size 6ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee r Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154211 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size B7 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154214 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size C3 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154215 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size C4 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154216 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size C5 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154217 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size C6 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154218 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size C7 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154221 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size D3 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154222 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size D4 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154223 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size D5 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154224 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size D6 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154225Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size D7 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154228 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size E3 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154229 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size E4 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154230 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size E5 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154231Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size E6 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154232 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size E7 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154235Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size F3 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154236 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size F4 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154237 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size F5 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154238 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size F6 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
| Jul 11, 2013 | Biomet, Inc. REF 154239 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size F7 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee Terminated |
HRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.