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) |
|---|---|---|---|
| Nov 30, 2015 | Aesculap, Inc. Columbus Revision Knee System, EnduRo Knee System
Product Usage:
The Columbus Revision Knee System and EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint. Terminated |
JWH | K083772 |
| Nov 9, 2015 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205, Non-Sterile, The Triathlon MIS Distal Capture is used when a surgeon elects to use a capt Terminated |
JWH | K123486 |
| Oct 21, 2015 | ConforMIS, Inc. ConFormis iTotal Posterior Stabilized Knee Replacement System-
ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and
ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT
Catalog Number:TPS1111111 Terminated |
JWH | K142161 K142404 |
| Oct 21, 2015 | ConforMIS, Inc. ConFormis iTotal CR Knee Replacement System-
iTOTAL CR, Right Knee
Catalog Number: M57250600020 (US)
M5725INT0600020 (OUS) Terminated |
JWH | K142161 |
| Oct 21, 2015 | ConforMIS, Inc. ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee
Catalog Number: M57250600010 (US)
M5725INT0600010 (OUS) Terminated |
JWH | K142161 |
| Oct 21, 2015 | ConforMIS, Inc. ConFormis iTotal CR Knee Replacement System-
ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT
ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT
Catalog Number: TCR1111111 Terminated |
JWH | K142161 |
| Oct 21, 2015 | ConforMIS, Inc. ConForMIS iUni Unicondylar Knee Replacement System-
iUNI G2, Right Medial
Catalog Number:M57220600220 (US)
M5722INT0600220 (OUS) Terminated |
JWH | K142161 K142404 |
| Aug 10, 2015 | Stryker Howmedica Osteonics Corp. Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm
Product Usage:
The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat Terminated |
JWH | K141056 |
| Jul 1, 2015 | Zimmer, Inc. Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component. Terminated |
JWH | K973412 |
| Jun 11, 2015 | Biomet, Inc. MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM
Knee joint replacement prostheses components include femoral, tibial, and patellar components. Terminated |
JWH | K142933 K915132 |
| May 19, 2015 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Triathlon femoral component.
Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile.
For use in total reconstructive replacement of the knee joint Terminated |
JWH | K042993 K070095 |
| May 19, 2015 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Scorpio femoral component.
Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile.
For use in total reconstructive replacement of the knee joint. Terminated |
JWH | K030978 K042343 +2 |
| May 14, 2015 | Stryker Howmedica Osteonics Corp. Kinemax Stem Extenders, 80 mm,
Product Usage:
Kinemax Cemented Stem Extenders are modular components designed to be mated with tibial baseplates or femoral components of the Modular Rotating Hinge (M Terminated |
JWH | K904208 |
| May 1, 2015 | Zimmer, Inc. NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10.
Intended to be used in total knee arthroplasty when there is insufficient bone in the distal femur. Terminated |
JWH | K960279 |
| Apr 1, 2015 | Zimmer, Inc. Brand Name: Persona Anterior Referencing Sizer with Locking Boom
The Persona Anterior Referencing Sizer is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Th Terminated |
JWH | K113369 |
| Mar 17, 2015 | Materialise N.V. Signature TKA GDE/MDL Set 04-05 (Femur & Tibia)
The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be Terminated |
JWH | K102795 |
| Mar 6, 2015 | Microport Orthopedics INC. EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics, Inc. Knee prosthesis component. Terminated |
JWH | K093552 |
| Feb 3, 2015 | Zimmer, Inc. Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee arthroplasty (orthopedic). Terminated |
JWH | K113369 |
| Jan 14, 2015 | Stelkast Co EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post Terminated |
JWH | K122883 |
| Jan 5, 2015 | Exactech, Inc. Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03.
Usage:Femoral implants Terminated |
JWH | K033883 |
| Dec 23, 2014 | Zimmer, Inc. Persona Cemented Tibial Broach Inserter/Extractor.
The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable instrument intended for use In multiple TKA procedures. The Perso Terminated |
JWH | K113369 |
| Dec 16, 2014 | Zimmer CAS PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer
The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the pos Terminated |
JWH | K131409 |
| Dec 12, 2014 | Smith & Nephew, Inc. LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & Nephew, knee prosthesis
Usage:orthopedic. Terminated |
JWH | K060742 |
| Dec 12, 2014 | Smith & Nephew, Inc. LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis
Usage:orthopedic. Terminated |
JWH | K060742 |
| Dec 12, 2014 | Smith & Nephew, Inc. LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis
Usage:orthopedic. Terminated |
JWH | K060742 |
| Dec 11, 2014 | ConforMIS, Inc. Conformis iTotal CR G2 Knee Replacement System
Catalog/Model #: M57250600010
Intended for use as a total knee replacement in patients with knee joint pain and disability. Terminated |
JWH | K140423 |
| Nov 21, 2014 | Materialise USA LLC Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperat Terminated |
JWH | K121640 |
| Nov 8, 2014 | Zimmer, Inc. Persona Stemmed 5 Degree Cemented Tibia
Product Usage:
This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, Terminated |
JWH | K113369 |
| Oct 23, 2014 | Zimmer, Inc. The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for
use in multiple total knee arthroplasty procedures. Per the Persona Surgical
technique, the Persona Tibial Artic Terminated |
JWH | K113369 |
| Oct 22, 2014 | Signal Medical Corporation Symmetric Total Knee Femoral Components
Product Usage:
Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replaceme Terminated |
JWH | K080199 |
| Sep 4, 2014 | Zimmer, Inc. PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Left Size 3-7 CD Top; Left Size 4-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Right Size 3-7 CD Top; Right Siz Terminated |
JWH | K113369 K123459 |
| Sep 4, 2014 | Zimmer, Inc. PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Size 3-5 CD Top; Size 6-9 CD Top; Size 3-5 EF Top; Size 6-9 EF Top; Size 10-11 EF Top; Size 6-9 GH Top; Size 10-1 Terminated |
JWH | K113369 K123459 |
| Sep 4, 2014 | Zimmer, Inc. PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left with the following: Size CD +0 mm Thickness Bottom(TB); Size CD +6 mm Thickness Bottom; Size EF +0 mm Thickness Bottom; Terminated |
JWH | K113369 K123459 |
| Sep 4, 2014 | Zimmer, Inc. PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional with the following: Left Size 3-9 CD Top; Left Size 3-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Left Size 3-9 Terminated |
JWH | K113369 K123459 |
| Sep 4, 2014 | Zimmer, Inc. PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional TOP with the following: L 3-5 CD; L 6-9 CD; L 3-5 EF; L 6-9 EF; L 10-11 EF; L 6-9 GH; L 10-12 Terminated |
JWH | K113369 K123459 |
| Sep 4, 2014 | Zimmer, Inc. Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number 6290-00-704.
Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut su Terminated |
JWH | K073286 |
| Sep 4, 2014 | Zimmer, Inc. Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number: 6290-00-703.
Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut Terminated |
JWH | K073286 |
| Sep 4, 2014 | Zimmer, Inc. Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number: 6290-00-702.
Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut Terminated |
JWH | K073286 |
| Sep 4, 2014 | Zimmer, Inc. Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-00-690.
Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut s Terminated |
JWH | K073286 |
| Sep 4, 2014 | Zimmer, Inc. PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM with the following: L CD +0MM; L CD +6MM; L EF +0MM;L EF +6MM; L GH +0MM; L GH +6MM; L J +0MM; L J +6MM; Terminated |
JWH | K113369 K123459 |
| Aug 26, 2014 | Zimmer, Inc. Knee Stem Extensions & Impactor Sleeve:
STEM IMPLANT 20MMDX145MM
STEM IMPLANT 22MMDX145MM
STEM IMPLANT 24MMDX145MM
SHARP FLUTED ST 20MMDX75MM
SHARP FLUTED ST 22MMDX75MM
SHARP FLTD ST 24MMDX75MM
SHARP Terminated |
JWH | K933785 |
| Aug 21, 2014 | Zimmer, Inc. Persona (TM) The Personalized Knee System
CPS Tibial Articular Surface Provisional Top
Nonsterile
TASP MLC L 3-5 CD TOP
TASP MLC L 6-9 CD TOP
TASP MLC L 3-5 EF TOP
TASP MLC L 6-9 EF TOP
TASP MLC L 10 Terminated |
JWH | K123459 |
| Aug 21, 2014 | Zimmer, Inc. Persona (TM) The Personalized Knee System
Tibial Articular Surface Provisional Bottom
Nonsterile
PSN A/S PROV L CD BOTTOM +0MM
PSN A/S PROV L CD BOTTOM +6MM
PSN A/S PROV L EF BOTTOM +0MM
PSN A/S PROV Terminated |
JWH | K123459 |
| Aug 21, 2014 | Zimmer, Inc. Persona (TM) The Personalized Knee System
UC Tibial Articular Surface Provisional Top
Nonsterile
TASP UC L 3-7 CD TOP
TASP UC L 4-11 EF TOP
TASP UC L 7-12 GH TOP
TASP UC L 9-12 J TOP Terminated |
JWH | K113369 |
| Aug 21, 2014 | Zimmer, Inc. Persona (TM) The Personalized Knee System
CR Tibial Articular Surface Provisional Top
Nonsterile
TASP CR L 3-9 CD TOP Terminated |
JWH | K123459 |
| Aug 21, 2014 | Zimmer, Inc. Persona (TM) The Personalized Knee System
Tibial Articular Surface Provisional Bottom
Nonsterile
TASP L CD BOTTOM, +0MM
TASP L CD BOTTOM, +6MM
TASP L EF BOTTOM, +0MM
TASP L EF BOTTOM, +6MM
TASP L GH Terminated |
JWH | K113369 |
| Aug 21, 2014 | Zimmer, Inc. Persona (TM) The Personalized Knee System
PS Tibial Articular Surface Provisional Top
Nonsterile
TASP PS L 3-5 CD TOP
TASP PS L 3-5 CD TOP
TASP PS L 3-5 CD TOP
TASP PS L 3-5 CD TOP
TASP PS L 3-5 CD Terminated |
JWH | K113369 |
| Aug 17, 2014 | Ortho Development Corporation Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY
Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the fem Terminated |
JWH | K060569 |
| Aug 17, 2014 | Ortho Development Corporation Tibila Insert UC, Balanced Knee System, REF163-3YYY
Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component Terminated |
JWH | K090705 |
| Aug 17, 2014 | Ortho Development Corporation PS Tibial Insert, REF 163-1XXX
Product Usage:
UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component Terminated |
JWH | K994370 |
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