510(k) K010810 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS
| Applicant | DePuy Orthopaedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Apr 18, 2001 |
| Received | Mar 19, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010810
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy Preservation Uni Knee All Poly Tibia, RM/LL, Sz 3, 11.5 mm, sterile; Product Code/REF 1498-11-310. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy Preservation Uni Knee All Poly Tibia, RM/LL, Sz 4, 11.5 mm, sterile; Product Code/REF 1498-11-410. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 2, 7.0 mm, sterile; Product Code/REF 1498-12-206. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 2, 9.5 mm, sterile; Product Code/REF 1498-12-208. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 4, 7.0 mm, sterile; Product code/REF 1498-12-406. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy Preservation Uni Knee All Poly Tibial, LM/RL, Sz 5, 7.0 mm, sterile; Product code/REF 1498-12-506. Terminated |
NJL | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy Preservation Uni Knee All Poly Tibial; polyethylene tibial insert RM/LL, Sz 2, 7.0 mm; Ref 1498-11-206. Terminated |
NJL | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy Preservation Uni Knee All Poly Tibial; polyethylene tibial insert RM/LL, Sz 3, 7.0 mm; Ref 1498-11-306. Terminated |
NJL | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy Preservation Uni Knee All Poly Tibial; polyethylene tibial insert RM/LL, Sz 3, 9.5 mm; Ref 1498-11-308. Terminated |
NJL | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy Preservation Uni Knee All Poly Tibial; polyethylene tibial insert RM/LL, Sz 3, 11.5 mm; Ref 1498-11-310. Terminated |
NJL | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy Preservation Uni Knee All Poly Tibial; polyethylene tibial insert RM/LL, Sz 4, 7.0 mm; Ref 1498-11-406. Terminated |
NJL | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy Preservation Uni Knee All Poly Tibial; polyethylene tibial insert RM/LL, Sz 4, 9.5 mm; Ref 1498-11-408. Terminated |
NJL | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy Preservation Uni Knee All Poly Tibial; polyethylene tibial insert LM/RL, Sz 2, 7.0 mm; Ref 1498-12-206. Terminated |
NJL | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy Preservation Uni Knee All Poly Tibial; polyethylene tibial insert LM/RL, Sz 2, 9.5 mm; Ref 1498-12-208. Terminated |
NJL | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy Preservation Uni Knee All Poly Tibial; polyethylene tibial insert LM/RL, Sz 3, 7.0 mm; Ref 1498-12-306. Terminated |
NJL | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy Preservation Uni Knee All Poly Tibial; polyethylene tibial insert LM/RL, Sz 3, 9.5 mm; Ref 1498-12-308. Terminated |
NJL | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy Preservation Uni Knee All Poly Tibial; polyethylene tibial insert LM/RL, Sz 4, 7.0 mm; Ref 1498-12-406. Terminated |
NJL | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy Preservation Uni Knee All Poly Tibial; polyethylene tibial insert LM/RL, Sz 4, 9.5 mm; Ref 1498-12-408. Terminated |
NJL | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy Preservation Uni Knee All Poly Tibial; polyethylene tibial insert LM/RL, Sz 5, 9.5 mm; Ref 1498-12-508. Terminated |
NJL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.