Panels › Orthopedic › Product code JWH · Class 2
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Regulation 888.3560
14510(k)s in 12 months (921 all time)
7recalls in 12 months (985 all time)
888recalls that name a 510(k)
Top companies in JWH
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer, Inc. | 51 | 304 |
| DePuy Orthopaedics, Inc. | 16 | 102 |
| Smith & Nephew, Inc. | 49 | 60 |
| Exactech, Inc. | 32 | 64 |
| Howmedica Osteonics | 32 | 61 |
| Zimmer Biomet, Inc. | 0 | 85 |
| Biomet, Inc. | 40 | 44 |
| Stryker Howmedica Osteonics | 0 | 64 |
| Conformis, Inc. | 40 | 19 |
| Encore Medical L.P. | 15 | 44 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, Sterile, RX. Terminated |
JWH | K023186 |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Beta, Ref 208-04-34, Sterile, RX. Terminated |
JWH | K023186 |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Sterile, RX. Terminated |
JWH | K023186 |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Sterile, RX. Terminated |
JWH | K023186 |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Beta, Ref 208-04-24, Sterile, RX. Terminated |
JWH | K023186 |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Alpha, Ref 208-04-23, Sterile, RX. Terminated |
JWH | K023186 |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile, RX. Terminated |
JWH | K023186 |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21, Sterile, RX. Terminated |
JWH | K023186 |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Beta, Ref 208-04-14, Sterile, RX. Terminated |
JWH | K023186 |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, Sterile, RX. Terminated |
JWH | K023186 |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12, Sterile, RX. Terminated |
JWH | K023186 |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11, Sterile, RX. Terminated |
JWH | K023186 |
| Sep 19, 2017 | Exactech, Inc. Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Sterile, RX. Terminated |
JWH | K023186 |
| Sep 15, 2017 | Encore Medical, Lp EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE
Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with Terminated |
JWH | K160342 |
| Sep 15, 2017 | Encore Medical, Lp EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE
Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused Terminated |
JWH | K160342 |
| Sep 14, 2017 | Smith & Nephew, Inc. smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R
Product The Revision Knee System Components are indicated for rheumatoid arthritis; post-tra Terminated |
JWH | K041106 |
| Aug 25, 2017 | Zimmer Biomet, Inc. AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804.
Product Usage:
For use in Total Knee Arthroplasty. Terminated |
JWH | K833921 |
| Aug 25, 2017 | Zimmer Biomet, Inc. AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802.
Product Usage:
For use in Total Knee Arthroplasty. Terminated |
JWH | K833921 |
| Aug 7, 2017 | Zimmer Biomet, Inc. Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302
For use during orthopaedic surgery for implantation of a prosthesis. Terminated |
JWH | K113369 |
| Aug 7, 2017 | Zimmer Biomet, Inc. Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301
For use during orthopaedic surgery for implantation of a prosthesis. Terminated |
JWH | K113369 K122765 |
| Aug 7, 2017 | Zimmer Biomet, Inc. Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302
For use during orthopaedic surgery for implantation of a prosthesis. Terminated |
JWH | K113369 |
| Aug 7, 2017 | Zimmer Biomet, Inc. Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301
For use during orthopaedic surgery for implantation of a prosthesis. Terminated |
JWH | K113369 |
| Aug 1, 2017 | Smith & Nephew, Inc. GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis Terminated |
JWH | K951987 |
| Jul 24, 2017 | ConforMIS, Inc. Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/
Intended for use as a total knee replacement in patients wi Terminated |
JWH | K161668 |
| Jun 19, 2017 | Exactech, Inc. Exactech Optetrak Logic CC 15mm Tibial Augment Screws Terminated |
JWH | K150890 |
| Jun 12, 2017 | Smith & Nephew, Inc. LEGION(R) TIB CONE IMPACTOR HEADS:
a) REF 71441972, ID 24MM
b) REF 71441971, ID 22MM
c) REF 71441973, ID 26MM
d) REF 71441974, ID 28MM
e) REF 71441975, ID 30MM Terminated |
JWH | K162775 |
| Jun 12, 2017 | Smith & Nephew, Inc. LEGION(R) FEM CONE IMPACTOR HEADS:
a) REF 71441976, ID 18MM
b) REF 71441977, ID 20MM
c) REF 71441978, ID 22MM Terminated |
JWH | K162775 |
| May 31, 2017 | Encore Medical, Lp 3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 01
The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused w Terminated |
JWH | K091956 |
| May 31, 2017 | Encore Medical, Lp 3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01,
The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused Terminated |
JWH | K091956 |
| Apr 28, 2017 | Zimmer Biomet, Inc. NexGen Offset Stem Extension, sizes 14mm and 17mm
For use in total arthroplasty. Terminated |
JWH | K933785 |
| Mar 27, 2017 | Zimmer Biomet, Inc. various polyethylene implants
Knees
Revision Tibial Tray Systems
Oxford Partial Knee
Orthopedic Salvage System
Vanguard Complete Knee System
Vanguard SSK Revision System
Biomet Patella
Maxim Complete Terminated |
JWH | K040770 K042757 +1 |
| 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 | K150496 |
| 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 | K150496 |
| 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 | K150496 |
| 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 | K150496 |
| Feb 3, 2017 | Encore Medical, Lp Empowr PS Knee Tibial Insert; Model 343-14-709
The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base Terminated |
JWH | K160342 |
| Jan 10, 2017 | ConforMIS, Inc. ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT
Catalog Number:TPS-111-1111
The iTotal PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disab Terminated |
JWH | K161668 |
| Jan 4, 2017 | Zimmer Biomet, Inc. Vanguard Total Knee System
Vanguard Open Box Femoral Components
Item Number: 183100
Description: VNGD PS OPEN INTL FEM RT 55
Item Number: 183102
Description: VNGD PS OPEN INTL FEM-RT 57.5
Item Number Terminated |
JWH | K023546 |
| Dec 15, 2016 | Zimmer Biomet, Inc. Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: 32-487264, and 79 MM Item No: 32-487265 Terminated |
JWH | K142933 |
| Nov 15, 2016 | Encore Medical, Lp Empowr Knee System
Product Usage:
Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure. Terminated |
JWH | K143242 |
| Oct 18, 2016 | ConforMIS, Inc. ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile
Catalog Number: TCR-111-1111.
Intended for use as a total knee replacement in patients with knee joint pain and disability wh Terminated |
JWH | K160025 |
| Oct 18, 2016 | Zimmer Biomet, Inc. Vanguard Distal Femoral Augment 75 X 5 RL/LM
Product Usage:
Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments ar Terminated |
JWH | K023546 |
| Oct 3, 2016 | Zimmer Biomet, Inc. Vanguard 360 Revision Knee System
Knee prostheses Terminated |
JWH | K093293 |
| Sep 19, 2016 | Encore Medical, Lp Empowr PS Knee System Box Cut Guide
The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant Terminated |
JWH | K160342 |
| Sep 19, 2016 | Encore Medical, Lp Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant. Terminated |
JWH | K160342 |
| 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 | K150496 |
| 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 | K150496 |
| 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 | K150496 |
| 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 | K150496 |
| 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 | K150496 |
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