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)
7recalls in 12 months (985 all time)
888recalls that name a 510(k)
Get daily alerts for JWHSample briefCSV

Top companies in JWH

DateFirm and productCodeLinked 510(k)
Nov 3, 2026CORIN MEDICAL, LTD.
Unity Knee ASC Modular Handle included in the Corin UNITY ASC INSTRUMENT SYSTEM. Part Number: 1232040.
Open, Classified
JWHK113060
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

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.