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) |
|---|---|---|---|
| Aug 17, 2014 | Ortho Development Corporation Patella 38mm, REF164-0038
Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact with the femoral component Terminated |
JWH | K994370 |
| Aug 15, 2014 | Biomet, Inc. Vanguard 360 Femoral Boss Reamer,
Label: REF 32-488474
VANGUARD 360 1NSTRUMENT
FEMORAL BOSS REAMER
NON-STERILE,
BIOMET ORTHOPEDICS
56 EAST BELL DRIVE
P.O. BOX 587 WARSAW, IN 46581 USA Terminated |
JWH | K093293 |
| Jun 27, 2014 | Zimmer, Inc. NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 8. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthes Terminated |
JWH | K043101 |
| Jun 27, 2014 | Zimmer, Inc. NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 7. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthes Terminated |
JWH | K043101 |
| Jun 27, 2014 | Zimmer, Inc. NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 6. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthes Terminated |
JWH | K043101 |
| Jun 27, 2014 | Zimmer, Inc. NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 5. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthes Terminated |
JWH | K043101 |
| Jun 27, 2014 | Zimmer, Inc. NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4+. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthe Terminated |
JWH | K043101 |
| Jun 27, 2014 | Zimmer, Inc. NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthes Terminated |
JWH | K043101 |
| Jun 27, 2014 | Zimmer, Inc. NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 3. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthes Terminated |
JWH | K043101 |
| Jun 27, 2014 | Zimmer, Inc. NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 2. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthes Terminated |
JWH | K043101 |
| Jun 27, 2014 | Zimmer, Inc. NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 1. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthes Terminated |
JWH | K043101 |
| May 13, 2014 | Ortho Development Corporation PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures. Terminated |
JWH | K994370 |
| Mar 20, 2014 | Zimmer, Inc. Natural-Knee II System:
POLY ULTRA TIB LT SZ00/9M
POLY ULTRA TIB LT SZ0/9MM
POLY ULTRA TIB LT SZ0/19M
POLY ULTRA TIB RT SZ0/13M
POLY ULTRA TIB RT SZ0/16M
ALL POLY ULTRA TIB LT SZ1
ALL POLY ULTRA TIB R Terminated |
JWH | K936159 |
| Mar 20, 2014 | Zimmer, Inc. Apollo" Revision/Constrained Knee System:
SZ0-16MM AK CCK TIB INSER
SZ1-11MM AK CCK TIB INSER
SZ1-16MM AK CCK TIB INSER
SZ1-22MM AK CCK TIB INSER
SZ1-30MM AK CCK TIB INSER
SZ2-11MM AK CCK TIB INSER
SZ Terminated |
JWH | K972501 |
| Mar 20, 2014 | Zimmer, Inc. Apollo" Knee System:
PS TIB INS SZ0/16MM APOLL
PS TIB INS SZ0/19MM APOLL
PS TIB INS SZ0/22MM APOLL
PS TIB INS SZ1/16MM APOLL
PS TIB INS SZ2/16M APOLLO
PS TIB INS SZ2/22MM APOLL
PS TIB INS SZ3/16MM APO Terminated |
JWH | None listed |
| Mar 20, 2014 | Zimmer, Inc. Apollo Knee Tibial Baseplate/Knee Tibial Insert:
CONG TIB INS SZ0/19MM APO
CONG TIB INS SZ0/22MM APO
CONG TIB INS SZ1/9MM APOL
CONG TIB INS SZ1/11MM APO
CONG TIB INS SZ1/19MM APO
CONG TIB INS SZ2/13MM Terminated |
JWH | K934381 |
| Mar 20, 2014 | Zimmer, Inc. Apollo" Knee System:
APOLLO PATELLA SZ0 28MM R Terminated |
JWH | K925242 |
| Mar 20, 2014 | Zimmer, Inc. Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Inserts:
N-K II CONS PS TIB INS SZ
N-K II CONS PS TIB INS SZ
N-K II CONS PS TIB INS SZ
N-K II CONS PS TIB INS SZ
N-K II CONS PS TIB INS SZ
N Terminated |
JWH | K983153 |
| Mar 20, 2014 | Zimmer, Inc. Natural-Knee II Constrained Knee System
NKII CCK TIB INS SZ00/0-L
NKII CCK TIB INS SZ1/2-LF
NKII CCK TIB INS SZ3-5 -L
NKII CCK TIB INS SZ00/0-R
NKII CCK TIB INS SZ3-5 -R
NKII CCK TIB INS SZ1/2-LF
NKII Terminated |
JWH | K973412 |
| Mar 20, 2014 | Zimmer, Inc. Natural-Knee II System
ULTRA CONG INS LT SZA/9MM
ULTRA CONG INS LT SZA/13M
ULTRA CONG INS LT SZA/19M
ULTRA CONG INS RT SZA/9MM
ULTRA CONG INS RT SZA/11M
ULTRA CONG INS RT SZA/13M
ULTRA CONG INS RT SZA Terminated |
JWH | None listed |
| Mar 20, 2014 | Zimmer, Inc. Natural-Knee Congruent Tibial Insert with Screw:
SF-CON TIB INS LT SZ1/2 1
SF-CON TIB INS RT SZ1/2 9
SF-CON TIB INS RT SZ3/4/5 Terminated |
JWH | K931651 |
| Mar 20, 2014 | Zimmer, Inc. Natural-Knee/Apollo" Knee:
M/B PAT SZ0 NATURAL-KNEE
M/B PAT SZ1 NATURAL-KNEE
M/B PAT SZ2 NATURAL-KNEE Terminated |
JWH | K935523 |
| Mar 20, 2014 | Zimmer, Inc. Natural-Knee
N-K II DOMED ALL-POLY PAT, SZ0
N-K II DOMED ALL-POLY PAT, SZ1 Terminated |
JWH | K936159 |
| Mar 20, 2014 | Zimmer, Inc. Gender Solutions" Natural-Knee Flex System:
N-K FLEX MBACK SZ 0 PAT
N-K FLEX MBACK SZ 1 PAT
N-K FLEX MBACK SZ 2 PAT Terminated |
JWH | K073286 |
| Mar 13, 2014 | DePuy Orthopaedics, Inc. REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right , X-Small, Sterile R
Qty 1
The S-ROM Hinged knee femoral component is used in revision surgeries when there Terminated |
JWH | K896048 |
| Mar 13, 2014 | DePuy Orthopaedics, Inc. REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left , X-Small, Sterile R
Qty 1
The S-ROM Hinged knee femoral component is used in revision surgeries when there Terminated |
JWH | K896048 |
| Feb 24, 2014 | DePuy Orthopaedics, Inc. PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT)
Used during primary total knee arthroplasty to improve patient mobility. Terminated |
JWH | K943462 |
| Feb 20, 2014 | Zimmer, Inc. FEM HD ION (various sizes) Terminated |
JWH | K892800 |
| Feb 20, 2014 | Zimmer, Inc. NEXGEN MIS TIBIA PLATE PR
NEXGEN TAPER PLUG
NEXGEN PRECOAT PEG TIB PL
NEXGEN MICRO ALL-POLY PAT
NEXGEN ALL-POLY PATELLA,
NEXGEN PRECOAT STEMMED TI
NEXGEN OPTION STEMMED TIB
NEXGEN STRAIGHT ST Terminated |
JWH | None listed |
| Feb 20, 2014 | Zimmer, Inc. I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST Terminated |
JWH | K830121 K872379 +1 |
| Dec 27, 2013 | Zimmer, Inc. NGK Stem Ext 24 x 245mm Terminated |
JWH | K130595 |
| Dec 13, 2013 | Biomet, Inc. G7 Acetabular Screw 6.5mmx35mm
Part Number: 010001000 Terminated |
JWH | None listed |
| Dec 13, 2013 | Aesculap, Inc. Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7 Terminated |
JWH | K083772 K122985 |
| Dec 11, 2013 | Zimmer, Inc. NexGen Complete Knee Solutions Stemmed Tibial Component Precoat
NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. The device is indicat Terminated |
JWH | K933785 |
| Dec 4, 2013 | Smith & Nephew Inc GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA
Orthopedic Terminated |
JWH | K032295 |
| Dec 4, 2013 | Smith & Nephew Inc GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA
Orthopedic Terminated |
JWH | K032295 |
| Dec 4, 2013 | Smith & Nephew Inc GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), REF 71421515, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA
Orthopedic Terminated |
JWH | K032295 |
| Dec 4, 2013 | Smith & Nephew Inc GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA
Orthopedic Terminated |
JWH | K032295 |
| Dec 4, 2013 | Smith & Nephew Inc GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA
Orthopedic Terminated |
JWH | K032295 |
| Dec 4, 2013 | Smith & Nephew Inc GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 71420806, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA
Orthopedic Terminated |
JWH | K032295 |
| Nov 27, 2013 | DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE"
MBT PUNCH NONCEMENTED
Size 4-7
HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used Terminated |
JWH | K032151 K033272 |
| Nov 27, 2013 | DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE"
MBT PUNCH CEMENTED
Size 4-7
HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used du Terminated |
JWH | K032151 K033272 |
| Nov 27, 2013 | DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE"
MBT PUNCH CEMENTED
Size 2-3
HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used du Terminated |
JWH | K032151 K033272 |
| Nov 27, 2013 | DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE"
MBT PUNCH CEMENTED
Size 1-1.5
HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used Terminated |
JWH | K032151 K033272 |
| Nov 27, 2013 | DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE"
MBT KEEL PUNCH NONCEMENTED
Size 4-7
HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray Terminated |
JWH | K032151 K033272 |
| Nov 27, 2013 | DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE"
MBT KEEL PUNCH NONCEMENTED
Size 2-3
HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tra Terminated |
JWH | K032151 K033272 |
| Nov 27, 2013 | DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE"
MBT KEEL PUNCH NONCEMENTED
Size 1-1.5
HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tr Terminated |
JWH | K032151 K033272 |
| Nov 27, 2013 | DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE"
MBT KEEL PUNCH CEMENTED
Size 4-7
HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray us Terminated |
JWH | K032151 K033272 |
| Nov 27, 2013 | DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE"
MBT KEEL PUNCH CEMENTED
Size 2-3
HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray Terminated |
JWH | K032151 K033272 |
| Nov 27, 2013 | DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE"
MBT KEEL PUNCH CEMENTED
SIZE 1-1.5
HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray Terminated |
JWH | K032151 K033272 |
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