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)
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 16, 2026 | Howmedica 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 |
JWH | K243817 |
| Aug 5, 2026 | United 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 |
JWH | K082424 |
| Jul 8, 2026 | Encore 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 |
JWH | K143242 |
| Jul 8, 2026 | Encore 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 |
JWH | K143242 |
| Feb 24, 2026 | Encore Medical, LP Brand Name: EMPOWR 3D KNEE
Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE
Model/Catalog Number: 341-16-707 Open, Classified |
JWH | K143242 |
| Feb 2, 2026 | Encore Medical, LP EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705 Open, Classified |
JWH | K143242 |
| Sep 8, 2025 | Waldemar 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 |
JWH | K202924 |
| Aug 8, 2025 | Encore 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 |
JWH | K143242 |
| Aug 8, 2025 | Encore 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 |
JWH | K143242 |
| Jul 17, 2025 | Encore 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 |
JWH | K143242 |
| Jul 17, 2025 | Encore 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 |
JWH | K143242 |
| Jul 2, 2025 | CORIN 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 |
JWH | K101994 K112891 +1 |
| Apr 30, 2025 | Waldemar 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 |
JWH | K202924 |
| Apr 30, 2025 | Waldemar 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 |
JWH | K202924 |
| Apr 30, 2025 | Waldemar 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 |
JWH | K202924 |
| Apr 30, 2025 | Waldemar 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 |
JWH | K202924 |
| Mar 24, 2025 | Zimmer, Inc. NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10 Open, Classified |
JWH | K042271 |
| Mar 17, 2025 | Waldemar 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 |
JWH | K202924 |
| Mar 17, 2025 | Waldemar 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 |
JWH | K202924 |
| Mar 17, 2025 | Waldemar 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 |
JWH | K202924 |
| Jan 28, 2025 | Zimmer, Inc. NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10 Open, Classified |
JWH | K960279 |
| Jan 28, 2025 | Zimmer, Inc. NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14 Open, Classified |
JWH | K960279 |
| Dec 26, 2024 | Encore 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 |
JWH | K143242 |
| Dec 23, 2024 | Encore Medical, LP EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706 Open, Classified |
JWH | K143242 |
| Oct 31, 2024 | Smith & Nephew Inc smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur prosthesis, metallic Open, Classified |
JWH | K112941 |
| Oct 31, 2024 | Smith & Nephew Inc smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic Open, Classified |
JWH | K962557 |
| Oct 30, 2024 | Smith & 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 |
JWH | K043440 |
| Oct 30, 2024 | Smith & 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 |
JWH | K043440 |
| Oct 7, 2024 | Howmedica 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 |
JWH | K141056 |
| Jul 18, 2024 | Waldemar 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 |
JWH | K143179 K151008 +1 |
| Jul 18, 2024 | Waldemar 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 |
JWH | K143179 K151008 +1 |
| Jun 18, 2024 | Exactech, 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 |
JWH | K160484 K932690 +1 |
| Jun 18, 2024 | Exactech, Inc. OPTETRAK Inset Patella, Item Numbers:
a) 200-05-23, 23MM;
b) 200-05-26, 26MM;
c) 200-05-29, 29MM Open, Classified |
JWH | K160484 K932690 +1 |
| Jun 18, 2024 | Exactech, 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 |
JWH | K160484 K932690 +1 |
| Jun 18, 2024 | Exactech, 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 |
JWH | K160484 K932690 +1 |
| May 31, 2024 | CORENTEC CO., LTD LOSPA Patella Component
Model/Catalog Number: 01.10.9XX
Software Version: N/A
Product Description: Patella Open, Classified |
JWH | K110404 K130673 +1 |
| May 31, 2024 | CORENTEC CO., LTD LOSPA Tibial Insert
Model/Catalog Number: See below
Software Version: N/A
Product Description: Tibial Insert Open, Classified |
JWH | K110404 K130673 +1 |
| Apr 22, 2024 | Zimmer, Inc. NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System. Open, Classified |
JWH | K031061 |
| Apr 17, 2024 | Conformis, Inc. Identity Imprint PS Tibial Tray Size 4: Lot 540287 Open, Classified |
JWH | K210191 K231233 |
| Jan 31, 2024 | Howmedica Osteonics Corp. TIBIAL BEARING INSERT SERIES P-S I ASSY
Intended for knee replacement
Product Number: 7291-0324 Open, Classified |
JWH | K914565 |
| Jan 31, 2024 | Howmedica Osteonics Corp. PS LIPPED TIBIAL INSERT ASSY DURACON
Intended for knee replacement
Product Number: 6742-1-416 Open, Classified |
JWH | None listed |
| Jan 31, 2024 | Howmedica Osteonics Corp. PS LIPPED TIBIAL INSERT ASSY DURACON
Intended for knee replacement
Product Number: 6742-1-413 Open, Classified |
JWH | K012172 |
| Jan 31, 2024 | Howmedica Osteonics Corp. PS LIPPED TIBIAL INSERT ASSY DURACON
Intended for knee replacement
Product Number: 6742-1-411 Open, Classified |
JWH | K012172 |
| Jan 31, 2024 | Howmedica Osteonics Corp. DUR PCA MTK REV INS RT
Intended for knee replacement
Product Number: 6728-2-711 Open, Classified |
JWH | K894403 K972863 |
| Jan 31, 2024 | Howmedica Osteonics Corp. DUR PCA MTK REV INS RT
Intended for knee replacement
Product Number: 6728-2-709 Open, Classified |
JWH | K894403 K972863 |
| Jan 31, 2024 | Howmedica Osteonics Corp. DUR PCA MTK REV INS LFT
Intended for knee replacement
Product Number: 6728-2-611 Open, Classified |
JWH | K894403 K972863 |
| Jan 31, 2024 | Howmedica Osteonics Corp. DUR PCA MTK REV INS LFT
Intended for knee replacement
Product Number: 6728-2-609 Open, Classified |
JWH | K894403 K972863 |
| Jan 31, 2024 | Howmedica Osteonics Corp. DURATION PLASTIC PATELLA-DURACON
Intended for knee replacement
Product Number: 6642-2-200 Open, Classified |
JWH | K032163 K032418 +1 |
| Jan 31, 2024 | Howmedica Osteonics Corp. DURATION A-P LIPPED TIB.INSERT-DURAC
Intended for knee replacement
Product Number: 6642-1-911 Open, Classified |
JWH | K032163 K032418 +1 |
| Jan 31, 2024 | Howmedica Osteonics Corp. DURATION A-P LIPPED TIB.INSERT-DURAC
Intended for knee replacement
Product Number: 6642-1-709 Open, Classified |
JWH | K032163 K032418 +1 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.