Attune
Attune Knee System FEMORAL POROCOAT CRUCIATE RETAINING NARROW SIZE 6N RIGHT CEMENTLESS
21manufacturers in China registered for this device type
417catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Beijing (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 21. All 21 manufacturers in China registered for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Record
| Listed by | Depuy (Ireland), Ireland |
|---|---|
| FDA product code | JWH |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K193057 |
| Record published | 2016-10-13 |
| Record revised | 2024-12-20 (version 9) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1504-01-226 | In distribution | |
| 1504-11-126 | In distribution | |
| 1516-01-006 | In distribution | |
| 1516-00-207 | In distribution | |
| 1517-00-420 | In distribution | |
| 1516-40-716 | In distribution | |
| 1516-40-407 | In distribution | |
| 1516-20-514 | In distribution | |
| 1516-40-620 | In distribution | |
| 1523-07-001 | In distribution | |
| 1516-20-608 | In distribution | |
| 1504-11-225 | In distribution | |
| 1516-00-312 | In distribution | |
| 1516-10-807 | In distribution | |
| 1520-20-608 | In distribution | |
| 1516-10-410 | In distribution | |
| 1516-00-208 | In distribution | |
| 1516-41-005 | In distribution | |
| 1520-20-412 | In distribution | |
| 1547-03-002 | In distribution | |
| 1504-11-224 | In distribution | |
| 1516-10-408 | In distribution | |
| 1517-00-608 | In distribution | |
| 1517-00-624 | In distribution | |
| 1517-00-606 | In distribution | |
| 1504-11-108 | In distribution | |
| 1516-10-209 | In distribution | |
| 1511-00-001 | In distribution | |
| 1517-00-708 | In distribution | |
| 1518-20-710 | In distribution | |
| 1549-03-001 | In distribution | |
| 1516-10-108 | In distribution | |
| 1547-07-002 | In distribution | |
| 1517-00-108 | In distribution | |
| 1516-00-809 | In distribution | |
| 1523-01-102 | In distribution | |
| 1516-20-610 | In distribution | |
| 1516-20-306 | In distribution | |
| 1518-20-405 | In distribution | |
| 1516-10-309 | In distribution | |
| 1523-03-202 | In distribution | |
| 1523-05-001 | In distribution | |
| 1504-11-101 | In distribution | |
| 1516-20-516 | In distribution | |
| 1516-10-808 | In distribution | |
| 1516-01-009 | In distribution | |
| 1516-00-407 | In distribution | |
| 1513-10-110 | In distribution | |
| 1516-00-107 | In distribution | |
| 1520-20-908 | In distribution | |
| 1516-40-920 | In distribution | |
| 1517-00-414 | In distribution | |
| 1516-10-909 | In distribution | |
| 1516-10-708 | In distribution | |
| 1516-00-106 | In distribution | |
| 1517-00-518 | In distribution | |
| 1516-10-508 | In distribution | |
| 1520-20-606 | In distribution | |
| 1517-01-020 | In distribution | |
| 1516-20-114 | In distribution | |
| 1516-10-609 | In distribution | |
| 1516-40-610 | In distribution | |
| 1516-10-605 | In distribution | |
| 1517-00-208 | In distribution | |
| 1518-20-506 | In distribution | |
| 1516-20-705 | In distribution | |
| 1504-11-125 | In distribution | |
| 1517-00-114 | In distribution | |
| 1516-20-616 | In distribution | |
| 1516-00-705 | In distribution | |
| 1516-10-307 | In distribution | |
| 1520-20-216 | In distribution | |
| 1517-00-112 | In distribution | |
| 1516-10-907 | In distribution | |
| 1518-20-612 | In distribution | |
| 1518-20-412 | In distribution | |
| 1516-00-507 | In distribution | |
| 1516-10-509 | In distribution | |
| 1516-00-807 | In distribution | |
| 1517-00-216 | In distribution | |
| 1516-01-007 | In distribution | |
| 1504-01-204 | In distribution | |
| 1516-11-006 | In distribution | |
| 1516-11-009 | In distribution | |
| 1516-00-209 | In distribution | |
| 1516-40-308 | In distribution | |
| 1516-10-809 | In distribution | |
| 1516-41-010 | In distribution | |
| 1517-00-516 | In distribution | |
| 1516-41-006 | In distribution | |
| 1506-70-004 | In distribution | |
| 1504-40-203 | In distribution | |
| 1516-41-012 | In distribution | |
| 1516-00-605 | In distribution | |
| 1516-00-606 | In distribution | |
| 1504-40-108 | In distribution | |
| 1516-41-018 | In distribution | |
| 1517-00-210 | In distribution | |
| 1547-06-002 | In distribution | |
| 1516-00-510 | In distribution | |
| 1516-00-412 | In distribution | |
| 1516-10-305 | In distribution | |
| 1517-00-220 | In distribution | |
| 1516-20-716 | In distribution | |
| 1516-40-820 | In distribution | |
| 1516-10-107 | In distribution | |
| 1547-06-004 | In distribution | |
| 1516-00-709 | In distribution | |
| 1516-20-216 | In distribution | |
| 1523-09-103 | In distribution | |
| 1511-01-205 | In distribution | |
| 1516-10-405 | In distribution | |
| 1506-70-008 | In distribution | |
| 1516-40-310 | In distribution | |
| 1516-00-212 | In distribution | |
| 1516-10-710 | In distribution | |
| 1516-10-308 | In distribution | |
| 1516-10-512 | In distribution | |
| 1504-01-105 | In distribution | |
| 1504-40-110 | In distribution | |
| 1506-70-001 | In distribution | |
| 1516-10-506 | In distribution | |
| 1516-20-912 | In distribution | |
| 1516-40-914 | In distribution | |
| 1517-00-310 | In distribution | |
| 1517-00-914 | In distribution | |
| 1516-00-912 | In distribution | |
| 1516-01-010 | In distribution | |
| 1516-10-707 | In distribution | |
| 1516-10-106 | In distribution | |
| 1516-10-505 | In distribution | |
| 1516-10-706 | In distribution | |
| 1517-00-410 | In distribution | |
| 1506-70-009 | In distribution | |
| 1516-10-507 | In distribution | |
| 1520-20-707 | In distribution | |
| 1516-20-714 | In distribution | |
| 1518-20-307 | In distribution | |
| 1518-20-214 | In distribution | |
| 1516-20-906 | In distribution | |
| 1516-41-007 | In distribution | |
| 1516-40-907 | In distribution | |
| 1549-01-001 | In distribution | |
| 1518-20-316 | In distribution | |
| 1516-00-109 | In distribution | |
| 1516-40-316 | In distribution | |
| 1513-16-060 | In distribution | |
| 1516-00-806 | In distribution | |
| 1516-00-305 | In distribution | |
| 1516-40-607 | In distribution | |
| 1518-20-107 | In distribution | |
| 1516-20-706 | In distribution | |
| 1516-20-212 | In distribution | |
| 1518-20-310 | In distribution | |
| 1517-00-912 | In distribution | |
| 1516-20-308 | In distribution | |
| 1516-20-214 | In distribution | |
| 1516-40-410 | In distribution | |
| 1516-00-508 | In distribution | |
| 1511-01-105 | In distribution | |
| 1520-20-306 | In distribution | |
| 1516-40-216 | In distribution | |
| 1516-10-306 | In distribution | |
| 1518-20-108 | In distribution | |
| 1516-00-712 | In distribution | |
| 1511-01-206 | In distribution | |
| 1516-20-607 | In distribution | |
| 1511-01-202 | In distribution | |
| 1516-00-907 | In distribution | |
| 1506-00-001 | In distribution | |
| 1516-20-812 | In distribution | |
| 1516-00-610 | In distribution | |
| 1517-00-818 | In distribution | |
| 1506-00-010 | In distribution | |
| 1516-10-810 | In distribution | |
| 1516-40-418 | In distribution | |
| 1547-01-002 | In distribution | |
| 1506-00-003 | In distribution | |
| 1523-09-001 | In distribution | |
| 1504-01-225 | In distribution | |
| 1520-20-314 | In distribution | |
| 1516-00-410 | In distribution | |
| 1517-01-014 | In distribution | |
| 1518-21-010 | In distribution | |
| 1516-00-505 | In distribution | |
| 1523-09-203 | In distribution | |
| 1516-20-507 | In distribution | |
| 1517-00-322 | In distribution | |
| 1518-20-106 | In distribution | |
| 1516-10-709 | In distribution | |
| 1547-09-001 | In distribution | |
| 1513-20-060 | In distribution | |
| 1504-40-206 | In distribution | |
| 1504-01-107 | In distribution | |
| 1516-00-905 | In distribution | |
| 1516-00-408 | In distribution | |
| 1504-11-102 | In distribution | |
| 1516-10-606 | In distribution | |
| 1516-21-016 | In distribution | |
| 1516-00-708 | In distribution | |
| 1517-01-012 | In distribution | |
| 1516-40-906 | In distribution | |
| 1516-40-414 | In distribution | |
| 1518-20-212 | In distribution | |
| 1516-10-610 | In distribution | |
| 1516-00-406 | In distribution | |
| 1516-00-110 | In distribution | |
| 1511-01-102 | In distribution | |
| 1518-20-810 | In distribution | |
| 1516-20-905 | In distribution | |
| 1547-08-004 | In distribution | |
| 1516-40-618 | In distribution | |
| 1517-00-616 | In distribution | |
| 1516-00-612 | In distribution | |
| 1504-01-103 | In distribution | |
| 1516-00-808 | In distribution | |
| 1518-20-516 | In distribution | |
| 1516-40-807 | In distribution | |
| 1517-00-722 | In distribution | |
| 1516-01-005 | In distribution | |
| 1513-18-110 | In distribution | |
| 1516-10-805 | In distribution | |
| 1516-10-310 | In distribution | |
| 1518-20-806 | In distribution | |
| 1517-00-712 | In distribution | |
| 1516-40-908 | In distribution | |
| 1517-00-926 | In distribution | |
| 1518-20-205 | In distribution | |
| 1516-20-605 | In distribution | |
| 1516-00-405 | In distribution | |
| 1518-20-414 | In distribution | |
| 1504-40-109 | In distribution | |
| 1516-20-710 | In distribution | |
| 1516-20-108 | In distribution | |
| 1516-00-509 | In distribution | |
| 1520-20-105 | In distribution | |
| 1504-40-208 | In distribution | |
| 1516-10-910 | In distribution | |
| 1516-21-010 | In distribution | |
| 1516-10-908 | In distribution | |
| 1520-20-312 | In distribution | |
| 1516-00-810 | In distribution | |
| 1516-00-307 | In distribution | |
| 1516-40-910 | In distribution | |
| 1516-00-105 | In distribution | |
| 1517-00-316 | In distribution | |
| 1511-01-203 | In distribution | |
| 1516-10-406 | In distribution | |
| 1516-20-206 | In distribution | |
| 1516-10-312 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy® | Microport Orthopedics Inc. | 4,423 |
| Exult Knee Replacement System | Corentec Co., Ltd. | 1,770 |
| Freedom | Maxx Orthopedics Inc. | 1,693 |
| Legion | Smith & Nephew, Inc. | 1,534 |
| MyKnee | Medacta International SA | 1,466 |
| Journey | Smith & Nephew, Inc. | 1,339 |
| Persona® | Zimmer, Inc. | 1,254 |
| DJO Surgical | Encore Medical, L.P. | 1,131 |
| U2 Total Knee System | United Orthopedic Corp. | 1,078 |
| CKS Plus | Shalby Advanced Technologies, Inc. | 1,024 |
| Lospa Modular Knee System | Corentec Co., Ltd. | 1,020 |
| Natural-Knee® | Zimmer, Inc. | 980 |
Showing 12 of 1,175. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170806 | 2017-06-15 |
| K160700 | 2016-06-10 |
Recalls Naming This Product
8 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Depuy Orthopaedics, Inc. | 510(k) number | 2023-02-15 | Class II | Labeling Change Control | The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material | 12 units | |
| Depuy Orthopaedics, Inc. | 510(k) number | 2022-01-05 | Class II | Nonconforming Material/Component | May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur. | 6 units | 2023-12-22 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2022-01-05 | Class II | Nonconforming Material/Component | May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur. | 3 units | 2023-12-22 |
| Depuy Orthopaedics, Inc. | UDI-DI | 2021-09-09 | Class II | Under Investigation by firm | Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery | 10 units | 2023-08-09 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2021-07-01 | Class II | Process change control | Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement | 7 units | 2023-02-01 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2021-02-22 | Class II | Packaging change control | Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be use | 102 units total (Domestic: 6 units, Foreign: 86 units) | 2023-10-11 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2018-04-16 | Class II | Process control | There may be burrs on the extraction hole threads. | 2 units | 2019-04-02 |
| Depuy Orthopaedics, Inc. | 510(k) number | 2018-04-16 | Class II | Process control | There may be burrs on the extraction hole threads. | 1 unit | 2019-04-02 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.