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) |
|---|---|---|---|
| Jan 18, 2024 | Exactech, 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 |
JWH | K160484 K932690 +2 |
| Dec 9, 2023 | Limacorporate S.p.A PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610 Open, Classified |
JWH | K213381 |
| Nov 2, 2023 | Corin Ltd Unity Total Knee System, Model Number 112.001.34.
Primary and revision total knee arthroplasty Open, Classified |
JWH | K113060 |
| Nov 2, 2023 | Corin Ltd Unity CR Femur Right, Size 6, Model Number 112.001.32
Primary and revision total knee arthroplasty Open, Classified |
JWH | K113060 |
| Oct 24, 2023 | Smith & Nephew, Inc. JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis Open, Classified |
JWH | K111711 K140555 |
| Oct 24, 2023 | Smith & Nephew, Inc. JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis Open, Classified |
JWH | K111711 K140555 |
| Oct 12, 2023 | Encore Medical, LP EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705 Open, Classified |
JWH | K143242 |
| Sep 20, 2023 | Smith & Nephew Inc smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint Open, Classified |
JWH | K112941 K230653 |
| Sep 19, 2023 | Encore Medical, LP DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106 Open, Classified |
JWH | K173723 |
| Jul 20, 2023 | Materialise N.V. MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-oper Completed |
JWH | K173445 K221337 |
| Jul 5, 2023 | Zimmer, Inc. NexGen Precoat Stemmed Tibial Plate Size 5 Terminated |
JWH | K173057 |
| Jul 3, 2023 | Waldemar Link GmbH & Co. KG (Mfg Site) LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement in skeletally mature patients.
Product Code: 880-3 Open, Classified |
JWH | K202924 |
| Jul 3, 2023 | Waldemar Link GmbH & Co. KG (Mfg Site) LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients.
Product Code: 880-3 Open, Classified |
JWH | K202924 |
| Jun 1, 2023 | Linkbio Corp. LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6
Tilastan, cemented.
Intended for primary and revision total knee replacement.
Item Number: 880-325/13 Open, Classified |
JWH | K202924 |
| Feb 27, 2023 | Encore Medical, LP EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706;
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF: 346-22-707;
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 8, 22MM, REF: 346-22-708;
EMPOWR VVC KNE Open, Classified |
JWH | K180930 |
| Jan 30, 2023 | Biomet, Inc. (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number: 183122
EXPANDED RECALL:
(2) Vanguard Knee System PS Open Box Femoral; Left; Open, Classified |
JWH | K113550 |
| Jan 30, 2023 | Biomet, Inc. (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses.
Item Number: 183104
(2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm
Item Numb Open, Classified |
JWH | K113550 |
| Dec 9, 2022 | Zimmer, Inc. NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02 Open, Classified |
JWH | K872379 |
| Dec 9, 2022 | Zimmer, Inc. NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01 Open, Classified |
JWH | K872379 |
| Dec 9, 2022 | Zimmer, Inc. NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02 Open, Classified |
JWH | K872379 |
| Dec 9, 2022 | Zimmer, Inc. NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01 Open, Classified |
JWH | K872379 |
| Dec 9, 2022 | Zimmer, Inc. NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02 Open, Classified |
JWH | K872379 |
| Dec 9, 2022 | Zimmer, Inc. NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01 Open, Classified |
JWH | K872379 |
| Nov 21, 2022 | Corin Ltd Unity Total Knee System.
Used for knee prosthesis in total knee replacement Terminated |
JWH | K113060 |
| Jun 27, 2022 | Smith & Nephew, Inc. (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186.
(2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166. Terminated |
JWH | K951987 |
| Jun 3, 2022 | Howmedica Osteonics Corp. Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600
Triathlon Tritanium Tibial Component (Size 5); Catalog Number 5536-B-500 Open, Classified |
JWH | K123486 |
| May 24, 2022 | Waldemar Link GmbH & Co. KG (Mfg Site) Tibial Component Modular. orthopedic prosthesis. Model Nos:
Small, W 16-2817/32
Medium, W 16-2817/35
Large, W 16-2817/37 Open, Classified |
JWH | K212742 |
| May 24, 2022 | Waldemar Link GmbH & Co. KG (Mfg Site) Tibial Component. orthopedic prosthesis. Model Nos:
Small, W 16-2817/02
Medium, W 16-2817/05
Large, W 16-2817/07 Open, Classified |
JWH | K212742 |
| May 24, 2022 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.:
X-Small, Right 15-3815/11,
Small, Right 15-3816/11,
Small, Left 15-3816/12,
Medium, Right 15-3 Open, Classified |
JWH | K212742 |
| May 24, 2022 | Waldemar Link GmbH & Co. KG (Mfg Site) Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis. Open, Classified |
JWH | K212742 |
| May 5, 2022 | Encore Medical, LP DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708 Open, Classified |
JWH | K143242 |
| Apr 19, 2022 | Smith & Nephew Inc LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5 Terminated |
JWH | K111711 K112941 |
| Feb 22, 2022 | Conformis, Inc. iTotal Identity Posterior Stabilised (PS) Knee Replacement System
Model Number: TPS-301-1113-020101 Completed |
JWH | K210809 |
| Jan 5, 2022 | DePuy Orthopaedics, Inc. ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries
Product Number: 154706001 Terminated |
JWH | K160700 |
| Jan 5, 2022 | DePuy Orthopaedics, Inc. ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries
Product Number: 154909003 Terminated |
JWH | K160700 |
| Oct 4, 2021 | Exactech, Inc. ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX).
NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022. Open, Classified |
JWH | None listed |
| Oct 4, 2021 | Exactech, Inc. OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX).
NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022. Open, Classified |
JWH | None listed |
| Oct 4, 2021 | Exactech, Inc. OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components.
NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022. Open, Classified |
JWH | None listed |
| Oct 4, 2021 | Exactech, Inc. TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following:
a. TRULIANT CR Tibial Inserts;
b. TRULIANT CR Slope + Tibial Inserts;
c. TRULIANT CR Slope ++ Tibial Inse Open, Classified |
JWH | K152170 K171045 |
| Oct 4, 2021 | Exactech, Inc. OPTETRAK Comprehensive Knee System custom devices labeled as the following:
a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX);
b. CUSTOM OPTETRAK CC TIBIAL INSERT (Product L Open, Classified |
JWH | None listed |
| Oct 4, 2021 | Exactech, Inc. OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following:
a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX;
b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012- Open, Classified |
JWH | K033883 K093360 +1 |
| Oct 4, 2021 | Exactech, Inc. OPTETRAK Comprehensive Knee System, labeled as the following:
a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200 Open, Classified |
JWH | K932690 K933494 |
| Sep 9, 2021 | DePuy Orthopaedics, Inc. ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement
Part Code:152307001 Terminated |
JWH | None listed |
| Jul 1, 2021 | Howmedica Osteonics Corp. Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700 Terminated |
JWH | K141056 |
| Jul 1, 2021 | DePuy Orthopaedics, Inc. ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty
Part Number: 1512-16-080 Terminated |
JWH | K160700 |
| May 19, 2021 | Smith & Nephew, Inc. LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis compon Terminated |
JWH | K043440 |
| May 12, 2021 | Encore Medical, LP DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185 Open, Classified |
JWH | K143242 |
| May 12, 2021 | Encore Medical, LP DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980 Open, Classified |
JWH | K143242 |
| Apr 9, 2021 | Howmedica Osteonics Corp. Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.
Catalog N Terminated |
JWH | K132624 K172326 |
| Feb 22, 2021 | DePuy Orthopaedics, Inc. ATTUNE FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral c Terminated |
JWH | K170806 |
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