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) |
|---|---|---|---|
| Jul 18, 2016 | Medtronic Sofamor Danek USA Inc RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF 90-SRK-311500, QTY: 1, STERILE R, Terminated |
JWH | K150496 |
| Jul 18, 2016 | Medtronic Sofamor Danek USA Inc RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, REF 90-SRK-311400, QTY: 1, STERILE R, Terminated |
JWH | K150496 |
| Jul 18, 2016 | Medtronic Sofamor Danek USA Inc RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 3R, REF 90-SRK-311300, QTY: 1, STERILE R, Terminated |
JWH | K150496 |
| Jun 23, 2016 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S
Product Usage:
Is a reusable instrument that is part of the Triathlon Primary total Terminated |
JWH | K143393 |
| May 9, 2016 | Stanmore Implants Worldwide Ltd. Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960 Terminated |
JWH | None listed |
| May 3, 2016 | Materialise USA LLC Signature TKA GDE/MDL Set 04-05
Patient-specific surgical guide and instrument set. Terminated |
JWH | K102795 |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R, REF 12 000 028, S&N 7500283, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | K072858 |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 027, S&N 7500282, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | K072858 |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 026, S&N 7500281, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | K072858 |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 025, S&N 7500280, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | K072858 |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 4 RIGHT, STERILE R, REF 12 000 024, S&N 7500279, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | K072858 |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 019, S&N 7500274, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | K072858 |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 6 LEFT, STERILE R, REF 12 000 018, S&N 7500273, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | K072858 |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R, REF 12 000 017, S&N 7500272, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | K072858 |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 0013, S&N 7500268, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | K072858 |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 0012, S&N 7500267, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | K072858 |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 0011, S&N 7500266, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | K072858 |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 2 RIGHT, STERILE R, REF 12 000 009, S&N 7500264, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | K072858 |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 10 LEFT, STERILE R, REF 12 000 006, S&N 7500261, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | K072858 |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 005, S&N 7500260, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | K072858 |
| Apr 21, 2016 | Smith & Nephew, Inc. TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 2 LEFT, STERILE R, REF 12 000 002, S&N 7500257, Smith & Nephew Orthopaedics AG
Product Usage: Tibial knee prosthesis Terminated |
JWH | K072858 |
| Apr 6, 2016 | Zimmer Manufacturing B.V. Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthroplasty. REF 42-5114-008-18 Terminated |
JWH | K113369 |
| Apr 6, 2016 | Zimmer Manufacturing B.V. Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For use in total knee arthroplasty. REF 42-5114-005-14 Terminated |
JWH | K113369 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 61 consists of all product under product code: JWH and same usage:
Item no:
598003712 STD PRECOAT TIBIA PLATE S
for use in total knee arthroplasty Terminated |
JWH | K933785 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 59 consists of all product under product code: JWH and same usage:
Item no:
42540000026 PSN ALL POLY PAT PLY 26MM
42540000029 PSN ALL POLY PAT PLY 29MM
42540000032 PSN ALL POLY PAT PLY 32MM
4 Terminated |
JWH | K113369 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 54 consists of all product under product code: JWH and same usage:
Item no:
596009900 NEXGEN TAPER PLUG
for use in total knee arthroplasty Terminated |
JWH | K991581 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 53 consists of all product under: product code: JWH and same usage:
Item no:
597002501 NEXGEN PRECOAT PEG TIB PL
597002502 NEXGEN PRECOAT PEG TIB PL
597003501 NEXGEN PRECOAT PEG TIB PL
597 Terminated |
JWH | K933785 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 51 consists of all product under product code: JWH and same usage:
Item no:
598603701 NEXGEN OPTION STEMMED TIB
598603702 NEXGEN OPTION STEMMED TIB
598604701 NEXGEN OPTION STEMMED TIB
598604 Terminated |
JWH | K872379 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 50 consists of all product under product code: JWH and same usage:
Item no:
595002701 NEXGEN MIS TIBIA PLATE PR
595002702 NEXGEN MIS TIBIA PLATE PR
595003701 NEXGEN MIS TIBIA PLATE PR
595003 Terminated |
JWH | K043101 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 49 consists of all product under product code: JWH and same usage:
Item no:
597206529 NEXGEN ALL-POLY PATELLA,
597206532 NEXGEN ALL-POLY PATELLA,
597206535 NEXGEN ALL-POLY PATELLA,
597206538 Terminated |
JWH | K933785 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 48 consists of all product under product code: JWH and same usage:
Item no:
597206526 NEXGEN ALL-POLY PATELLA,
for use in total knee arthroplasty Terminated |
JWH | K960279 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 45 consists of all product under product code: JWH and same usage:
Item no:
511007020 MGII KNEE SLF-TAP BONE ST
511007025 MGII KNEE SLF-TAP BONE ST
511007030 MGII KNEE SLF-TAP BONE ST
511007 Terminated |
JWH | K892800 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 35 consists of all product under product code: JWH and same usage:
Item no:
522007300 I/B II KNEE FLUTED ROD, 1
for use in total knee arthroplasty Terminated |
JWH | K872379 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 34 consists of all product under product code: JWH and same usage:
Item no:
522001700 I/B II KNEE DOMED PATELLA
522001800 I/B II KNEE DOMED PATELLA
522001900 I/B II KNEE DOMED PATELLA
for us Terminated |
JWH | K892800 |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 26 consists of all product under product code: JWH and same usage:
Item no:
234703104 DISTAL MEDIAL FEMORAL CON
234703206 DISTAL MEDIAL FEMORAL CON
234703208 DISTAL MEDIAL FEMORAL CON
234800 Terminated |
JWH | K892800 |
| Feb 22, 2016 | Zimmer Biomet, Inc. NKII CSTI Porous Femoral
NKII NP Femoral
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
variou sizes
Product Usage "" The Natural-Knee II System with Cancello Terminated |
JWH | K936159 |
| Feb 22, 2016 | Zimmer Biomet, Inc. CR Flex GSF Precoat Fem
Natural Knee GSF NP Flex
Natural Knee GSF POR Flex
Natural Knee GSM NP Flex
Natural Knee GSM POR Flex
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer Terminated |
JWH | K071107 |
| Feb 22, 2016 | Zimmer Biomet, Inc. NexGen Knee CR Option Fem
NexGen Knee CR Porous Fem
NexGen Knee CR Precoat Fem
NexGen Knee LPS Porous Fem
NexGen Knee LPS Precoat Fem
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, Terminated |
JWH | K933785 |
| Feb 22, 2016 | Zimmer Biomet, Inc. NexGen Knee LPS Porous FEM
NexGen Knee LPS Option FEM
NexGen Knee Lock FEM
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
various sizes
Product Usage "" This Terminated |
JWH | K960279 |
| Feb 22, 2016 | Zimmer Biomet, Inc. NexGen Knee CR Porous FEM
NexGen Knee CR Precoat FEM
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
various sizes
"" This device is indicated for patients wit Terminated |
JWH | K962196 |
| Feb 22, 2016 | Zimmer Biomet, Inc. NexGen LPS-FLEX Option Femoral
NexGen LPS-FLEX Precoat Femoral
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
various sizes
Product Usage "" This device is in Terminated |
JWH | K991581 |
| Feb 22, 2016 | Zimmer Biomet, Inc. NexGen CR-FLEX Option FEM
NexGen CR-FLEX Precoat FEM
NexGen CR-FLEX Porous FEM
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
various sizes
"" This device is Terminated |
JWH | K023211 |
| Feb 22, 2016 | Zimmer Biomet, Inc. LPS-FLEX GSF OPT
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
Various sizes
Product Usage "" This device is indicated for patients with severe knee pain an Terminated |
JWH | K060370 |
| Jan 28, 2016 | ConforMIS, Inc. Conformis iTotal Cruciate Retaining (CR) Knee Replacement System
Model: TCR-111-1111 Terminated |
JWH | K142161 |
| Jan 18, 2016 | Smith & Nephew, Inc. LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosthesis, augment. Terminated |
JWH | K043440 |
| Jan 5, 2016 | Zimmer Manufacturing B.V. NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component Option CR/PS/LPS Size Stemmed 3. Tibial component of implanted knee prosthe Terminated |
JWH | K933785 |
| Jan 4, 2016 | Smith & Nephew, Inc. Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490
knee implant. Terminated |
JWH | K951987 |
| Dec 17, 2015 | Arthrex, Inc. Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 Terminated |
JWH | K081127 |
| Dec 2, 2015 | Zimmer Manufacturing B.V. Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3;
Lot Number:62460264.
Indicated for patients with severe knee Terminated |
JWH | K933785 |
| Dec 2, 2015 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, modular offset adapto Terminated |
JWH | K973164 |
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