510(k) K150496 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Total Knee Arthroplasty System
| Applicant | Responsive Orthopedics, LLC, Wayzata MN, US |
| Decision | Substantially Equivalent, Jun 12, 2015 |
| Received | Feb 25, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150496
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2017 | Medtronic Sofamor Danek USA Inc Poly Component Trial, MPCS, packaged in the following sizes and configurations:
a) Poly Component Trial - MPCS 3x10L, REF 90-SRK-192310
b) Poly Component Trial - MPCS 3x10R, REF 90-SRK-191310
c) Pol Terminated |
JWH | None listed |
| Feb 20, 2017 | Medtronic Sofamor Danek USA Inc Poly Component Trial, UCCS, packaged in the following sizes and configurations:
a) Poly Comp Trial - UCCS 3x10, REF 90-SRK-170310
b) Poly Comp Trial - UCCS 3x12, REF 90-SRK-170312
c) Poly Comp Trial Terminated |
JWH | None listed |
| Feb 20, 2017 | Medtronic Sofamor Danek USA Inc Poly Component Trial, CR, packaged in the following sizes and configurations:
a) Poly Component Trial - CR 3x10, REF 90-SRK-160310
b) Poly Component Trial - CR 3x12, REF 90-SRK-160312
c) Poly Compon Terminated |
JWH | None listed |
| Feb 20, 2017 | Medtronic Sofamor Danek USA Inc Poly Component Trial, PS, packaged in the following sizes and configurations:
a) Poly Component Trial - PS 3x10, REF 90-SRK-180310
b) Poly Component Trial - PS 3x12, REF 90-SRK-180312
c) Poly Compon Terminated |
JWH | None listed |
| Jul 18, 2016 | Medtronic Sofamor Danek USA Inc RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 3R, REF 90-SRK-311300, QTY: 1, STERILE R, Terminated |
JWH | None listed |
| Jul 18, 2016 | Medtronic Sofamor Danek USA Inc RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, REF 90-SRK-311400, QTY: 1, STERILE R, Terminated |
JWH | None listed |
| Jul 18, 2016 | Medtronic Sofamor Danek USA Inc RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF 90-SRK-311500, QTY: 1, STERILE R, Terminated |
JWH | None listed |
| Jul 18, 2016 | Medtronic Sofamor Danek USA Inc RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 3L, REF 90-SRK-312300, QTY: 1, STERILE R, Terminated |
JWH | None listed |
| Jul 18, 2016 | Medtronic Sofamor Danek USA Inc TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement . Terminated |
JWH | None listed |
| Jul 18, 2016 | Medtronic Sofamor Danek USA Inc TIBIAL TRAY , SIZE 3, REF 90-SRK-200300, QTY: 1, STERILE R, total knee replacement Terminated |
JWH | None listed |
| Jul 18, 2016 | Medtronic Sofamor Danek USA Inc TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement Terminated |
JWH | None listed |
| Jul 18, 2016 | Medtronic Sofamor Danek USA Inc TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.