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

DateFirm and productCodeLinked 510(k)
Sep 16, 2026Howmedica Osteonics Corp.
ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5-0910 SCORPIO C-DOME PATELLA 73-2710 SC
Open, Classified
JWHK243817
Aug 5, 2026United Orthopedic Corp.
Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Produ
Open, Classified
JWHK082424
Jul 8, 2026Encore Medical, LP
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty.
Open, Classified
JWHK143242
Jul 8, 2026Encore Medical, LP
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee devices are intended for knee arthroplasty.
Open, Classified
JWHK143242
Feb 24, 2026Encore Medical, LP
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
Open, Classified
JWHK143242
Feb 2, 2026Encore Medical, LP
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Open, Classified
JWHK143242
Sep 8, 2025Waldemar Link GmbH & Co. KG (Mfg Site)
LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
Open, Classified
JWHK202924
Aug 8, 2025Encore Medical, LP
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are intended for treatment o
Open, Classified
JWHK143242
Aug 8, 2025Encore Medical, LP
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are intended for treatment o
Open, Classified
JWHK143242
Jul 17, 2025Encore Medical, LP
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 Software Version: NA Product Description: Enovis" knee devices are i
Open, Classified
JWHK143242
Jul 17, 2025Encore Medical, LP
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 Software Version: NA Product Description: Enovis" knee devices are i
Open, Classified
JWHK143242
Jul 2, 2025CORIN MEDICAL, LTD.
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-5255
Open, Classified
JWHK101994
K112891 +1
Apr 30, 2025Waldemar Link GmbH & Co. KG (Mfg Site)
Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - cemented lg), (5) 880-
Open, Classified
JWHK202924
Apr 30, 2025Waldemar Link GmbH & Co. KG (Mfg Site)
L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) 880-321/12 (Sz. 1-2 - cemented sm), (4) 880-321/22 (Sz. 1-2 - cemented lg), (5)
Open, Classified
JWHK202924
Apr 30, 2025Waldemar Link GmbH & Co. KG (Mfg Site)
Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2 - cemented lg), (5)
Open, Classified
JWHK202924
Apr 30, 2025Waldemar Link GmbH & Co. KG (Mfg Site)
Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 880-301/21 (Sz. 1-2 - cemented lg), (5) 88
Open, Classified
JWHK202924
Mar 24, 2025Zimmer, Inc.
NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10
Open, Classified
JWHK042271
Mar 17, 2025Waldemar Link GmbH & Co. KG (Mfg Site)
Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
Open, Classified
JWHK202924
Mar 17, 2025Waldemar Link GmbH & Co. KG (Mfg Site)
Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12
Open, Classified
JWHK202924
Mar 17, 2025Waldemar Link GmbH & Co. KG (Mfg Site)
Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
Open, Classified
JWHK202924
Jan 28, 2025Zimmer, Inc.
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
Open, Classified
JWHK960279
Jan 28, 2025Zimmer, Inc.
NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14
Open, Classified
JWHK960279
Dec 26, 2024Encore Medical, LP
EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
Open, Classified
JWHK143242
Dec 23, 2024Encore Medical, LP
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Open, Classified
JWHK143242
Oct 31, 2024Smith & Nephew Inc
smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur prosthesis, metallic
Open, Classified
JWHK112941
Oct 31, 2024Smith & Nephew Inc
smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic
Open, Classified
JWHK962557
Oct 30, 2024Smith & Nephew Inc
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Open, Classified
JWHK043440
Oct 30, 2024Smith & Nephew Inc
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Open, Classified
JWHK043440
Oct 7, 2024Howmedica Osteonics Corp.
Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee S
Open, Classified
JWHK141056
Jul 18, 2024Waldemar Link GmbH & Co. KG (Mfg Site)
Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75mm 16-2817/32 Tibial
Open, Classified
JWHK143179
K151008 +1
Jul 18, 2024Waldemar Link GmbH & Co. KG (Mfg Site)
Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15
Open, Classified
JWHK143179
K151008 +1
Jun 18, 2024Exactech, Inc.
OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM
Open, Classified
JWHK160484
K932690 +1
Jun 18, 2024Exactech, Inc.
OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
Open, Classified
JWHK160484
K932690 +1
Jun 18, 2024Exactech, Inc.
OPTETRAK One Peg Patella,, Item Numbers: a) 200-03-26, 26MM; b) 200-03-29, 29MM; c) 200-03-32, 32MM; d) 200-03-35, 35MM; e) 200-03-38, 38MM; f) 200-03-41, 41MM
Open, Classified
JWHK160484
K932690 +1
Jun 18, 2024Exactech, Inc.
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
Open, Classified
JWHK160484
K932690 +1
May 31, 2024CORENTEC CO., LTD
LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella
Open, Classified
JWHK110404
K130673 +1
May 31, 2024CORENTEC CO., LTD
LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
Open, Classified
JWHK110404
K130673 +1
Apr 22, 2024Zimmer, Inc.
NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
Open, Classified
JWHK031061
Apr 17, 2024Conformis, Inc.
Identity Imprint PS Tibial Tray Size 4: Lot 540287
Open, Classified
JWHK210191
K231233
Jan 31, 2024Howmedica Osteonics Corp.
TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324
Open, Classified
JWHK914565
Jan 31, 2024Howmedica Osteonics Corp.
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-416
Open, Classified
JWHNone listed
Jan 31, 2024Howmedica Osteonics Corp.
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-413
Open, Classified
JWHK012172
Jan 31, 2024Howmedica Osteonics Corp.
PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-411
Open, Classified
JWHK012172
Jan 31, 2024Howmedica Osteonics Corp.
DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711
Open, Classified
JWHK894403
K972863
Jan 31, 2024Howmedica Osteonics Corp.
DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-709
Open, Classified
JWHK894403
K972863
Jan 31, 2024Howmedica Osteonics Corp.
DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611
Open, Classified
JWHK894403
K972863
Jan 31, 2024Howmedica Osteonics Corp.
DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609
Open, Classified
JWHK894403
K972863
Jan 31, 2024Howmedica Osteonics Corp.
DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200
Open, Classified
JWHK032163
K032418 +1
Jan 31, 2024Howmedica Osteonics Corp.
DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911
Open, Classified
JWHK032163
K032418 +1
Jan 31, 2024Howmedica Osteonics Corp.
DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709
Open, Classified
JWHK032163
K032418 +1

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