ClearanceBrief
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)
6recalls in 12 months (984 all time)
887recalls that name a 510(k)
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Top companies in JWH

Company510(k)sRecalls
Zimmer, Inc.51304
DePuy Orthopaedics, Inc.16102
Smith & Nephew, Inc.4960
Exactech, Inc.3264
Howmedica Osteonics3261
Zimmer Biomet, Inc.085
Biomet, Inc.4044
Stryker Howmedica Osteonics064
Conformis, Inc.4019
Encore Medical L.P.1544
DateFirm and productCodeLinked 510(k)
Jan 31, 2024Howmedica Osteonics Corp.
LARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement Product Number: 6637-4-231
Open, Classified		 JWHK936008
Jan 31, 2024Howmedica Osteonics Corp.
PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031
Open, Classified		 JWHK936008
Jan 31, 2024Howmedica Osteonics Corp.
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-931
Open, Classified		 JWHK940861
Jan 31, 2024Howmedica Osteonics Corp.
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-928
Open, Classified		 JWHK940861
Jan 31, 2024Howmedica Osteonics Corp.
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-831
Open, Classified		 JWHK940861
Jan 31, 2024Howmedica Osteonics Corp.
LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631
Open, Classified		 JWHK940861
Jan 31, 2024Howmedica Osteonics Corp.
LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-328
Open, Classified		 JWHK940861
Jan 31, 2024Howmedica Osteonics Corp.
LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-231
Open, Classified		 JWHK940861
Jan 31, 2024Howmedica Osteonics Corp.
LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-228
Open, Classified		 JWHK940861
Jan 31, 2024Howmedica Osteonics Corp.
LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-028
Open, Classified		 JWHNone listed
Jan 31, 2024Howmedica Osteonics Corp.
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J
Open, Classified		 JWHNone listed
Jan 31, 2024Howmedica Osteonics Corp.
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J
Open, Classified		 JWHNone listed
Jan 31, 2024Howmedica Osteonics Corp.
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-28J
Open, Classified		 JWHNone listed
Jan 31, 2024Howmedica Osteonics Corp.
Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0910
Open, Classified		 JWHK051948
K052917 +1
Jan 31, 2024Howmedica Osteonics Corp.
Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0908
Open, Classified		 JWHK030978
Jan 31, 2024Howmedica Osteonics Corp.
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3910
Open, Classified		 JWHNone listed
Jan 31, 2024Howmedica Osteonics Corp.
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710
Open, Classified		 JWHK051948
K052917 +1
Jan 31, 2024Howmedica Osteonics Corp.
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708
Open, Classified		 JWHK051948
K052917 +1
Jan 31, 2024Howmedica Osteonics Corp.
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3508
Open, Classified		 JWHK051948
K052917 +1
Jan 31, 2024Howmedica Osteonics Corp.
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308
Open, Classified		 JWHK051948
K052917 +1
Jan 31, 2024Howmedica Osteonics Corp.
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110
Open, Classified		 JWHK051948
K052917 +1
Jan 31, 2024Howmedica Osteonics Corp.
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-2910
Open, Classified		 JWHK962152
Jan 31, 2024Howmedica Osteonics Corp.
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-2710
Open, Classified		 JWHK962152
Jan 31, 2024Howmedica Osteonics Corp.
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-2110
Open, Classified		 JWHK962152
Jan 31, 2024Howmedica Osteonics Corp.
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-0910
Open, Classified		 JWHK962152
Jan 31, 2024Howmedica Osteonics Corp.
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-0710
Open, Classified		 JWHK962152
Jan 31, 2024Howmedica Osteonics Corp.
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement Part Number: 73-0510
Open, Classified		 JWHK962152
Jan 31, 2024Howmedica Osteonics Corp.
SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-0110
Open, Classified		 JWHK962152
Jan 31, 2024Howmedica Osteonics Corp.
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910
Open, Classified		 JWHK011643
Jan 31, 2024Howmedica Osteonics Corp.
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908
Open, Classified		 JWHK011643
Jan 31, 2024Howmedica Osteonics Corp.
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324
Open, Classified		 JWHK041591
Jan 31, 2024Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524
Open, Classified		 JWHK994128
Jan 31, 2024Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521
Open, Classified		 JWHK994128
Jan 31, 2024Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518
Open, Classified		 JWHK994128
Jan 31, 2024Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516
Open, Classified		 JWHK994128
Jan 31, 2024Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514
Open, Classified		 JWHK994128
Jan 31, 2024Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512
Open, Classified		 JWHK994128
Jan 31, 2024Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510
Open, Classified		 JWHK994128
Jan 31, 2024Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321
Open, Classified		 JWHK994128
Jan 31, 2024Howmedica Osteonics Corp.
SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524
Open, Classified		 JWHK884398
Jan 31, 2024Howmedica Osteonics Corp.
SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515
Open, Classified		 JWHK884398
Jan 31, 2024Howmedica Osteonics Corp.
SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032
Open, Classified		 JWHK863668
Jan 31, 2024Howmedica Osteonics Corp.
SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0030
Open, Classified		 JWHK863668
Jan 31, 2024Howmedica Osteonics Corp.
SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028
Open, Classified		 JWHK863668
Jan 31, 2024Howmedica Osteonics Corp.
SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026
Open, Classified		 JWHK863668
Jan 18, 2024Exactech, Inc.
Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02-0032, c) 02-023-02-0035, d) 02-023-02-0038, e) 02-024-35-1512, f) 02-024-35-1515, g) 02-024-35-1519,
Open, Classified		 JWHK223252
Jan 18, 2024Exactech, Inc.
Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-35-3511, h) 02-022-
Open, Classified		 JWHK152170
K171045
Jan 18, 2024Exactech, Inc.
Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
Open, Classified		 JWHK033883
Jan 18, 2024Exactech, Inc.
Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013
Open, Classified		 JWHK111400
K150890
Jan 18, 2024Exactech, Inc.
Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-32, j) 200-07-35,
Open, Classified		 JWHK160484
K932690 +2

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