Attune
ATTUNE KNEE SYSTEM TIBIAL INSERT FIXED BEARING MEDIAL STABILIZED RIGHT AOX 10, 16mm
8manufacturers in China registered for this device type
161catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Depuy (Ireland), Ireland |
|---|---|
| FDA product code | OIY |
| Device type | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K111433 |
| Record published | 2015-09-24 |
| Record revised | 2024-12-06 (version 7) |
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 |
|---|---|---|
| 1516-40-814 | In distribution | |
| 1518-20-705 | In distribution | |
| 1520-21-016 | In distribution | |
| 1516-20-914 | In distribution | |
| 1516-20-814 | In distribution | |
| 1516-40-518 | In distribution | |
| 1516-20-916 | In distribution | |
| 1518-20-510 | In distribution | |
| 1518-20-812 | In distribution | |
| 1520-20-716 | In distribution | |
| 1516-20-112 | In distribution | |
| 1506-00-009 | In distribution | |
| 1518-20-716 | In distribution | |
| 1516-40-406 | In distribution | |
| 1516-20-116 | In distribution | |
| 1516-40-705 | In distribution | |
| 1516-20-314 | In distribution | |
| 1520-21-006 | In distribution | |
| 1516-20-312 | In distribution | |
| 1520-20-805 | In distribution | |
| 1518-20-305 | In distribution | |
| 1516-20-410 | In distribution | |
| 1506-70-007 | In distribution | |
| 1516-40-606 | In distribution | |
| 1520-20-607 | In distribution | |
| 1520-21-007 | In distribution | |
| 1516-21-007 | In distribution | |
| 1516-40-206 | In distribution | |
| 1516-40-918 | In distribution | |
| 1516-40-210 | In distribution | |
| 1518-20-116 | In distribution | |
| 1516-40-205 | In distribution | |
| 1518-20-406 | In distribution | |
| 1516-40-516 | In distribution | |
| 1516-40-506 | In distribution | |
| 1516-40-318 | In distribution | |
| 1520-20-206 | In distribution | |
| 1520-20-107 | In distribution | |
| 1516-21-008 | In distribution | |
| 1516-20-107 | In distribution | |
| 1516-20-908 | In distribution | |
| 1516-40-616 | In distribution | |
| 1506-70-006 | In distribution | |
| 1520-20-516 | In distribution | |
| 1516-40-707 | In distribution | |
| 1516-40-420 | In distribution | |
| 1516-20-707 | In distribution | |
| 1520-20-407 | In distribution | |
| 1516-20-512 | In distribution | |
| 1520-20-416 | In distribution | |
| 1520-20-308 | In distribution | |
| 1506-00-006 | In distribution | |
| 1516-40-805 | In distribution | |
| 1520-20-207 | In distribution | |
| 1516-40-214 | In distribution | |
| 1516-40-408 | In distribution | |
| 1520-20-612 | In distribution | |
| 1516-40-412 | In distribution | |
| 1516-40-508 | In distribution | |
| 1516-40-514 | In distribution | |
| 1516-20-806 | In distribution | |
| 1516-40-614 | In distribution | |
| 1516-40-307 | In distribution | |
| 1518-20-306 | In distribution | |
| 1518-20-105 | In distribution | |
| 1520-20-810 | In distribution | |
| 1516-41-008 | In distribution | |
| 1520-20-910 | In distribution | |
| 1520-20-116 | In distribution | |
| 1516-40-818 | In distribution | |
| 1518-20-912 | In distribution | |
| 1516-20-110 | In distribution | |
| 1516-20-712 | In distribution | |
| 1506-00-008 | In distribution | |
| 1518-20-614 | In distribution | |
| 1520-20-305 | In distribution | |
| 1520-20-808 | In distribution | |
| 1520-20-208 | In distribution | |
| 1516-41-020 | In distribution | |
| 1518-20-712 | In distribution | |
| 1516-20-416 | In distribution | |
| 1516-40-107 | In distribution | |
| 1516-20-506 | In distribution | |
| 1516-40-718 | In distribution | |
| 1518-10-041 | In distribution | |
| 1520-20-210 | In distribution | |
| 1516-40-405 | In distribution | |
| 1520-20-906 | In distribution | |
| 1520-20-405 | In distribution | |
| 1518-20-905 | In distribution | |
| 1516-40-720 | In distribution | |
| 1506-70-003 | In distribution | |
| 1518-20-816 | In distribution | |
| 1516-40-212 | In distribution | |
| 1516-40-706 | In distribution | |
| 1516-40-708 | In distribution | |
| 1516-40-314 | In distribution | |
| 1516-40-810 | In distribution | |
| 1516-20-316 | In distribution | |
| 1518-20-208 | In distribution | |
| 1516-40-306 | In distribution | |
| 1520-20-406 | In distribution | |
| 1520-21-005 | In distribution | |
| 1516-21-012 | In distribution | |
| 1520-20-114 | In distribution | |
| 1516-20-405 | In distribution | |
| 1516-40-320 | In distribution | |
| 1516-20-907 | In distribution | |
| 1516-20-106 | In distribution | |
| 1516-20-810 | In distribution | |
| 1516-41-016 | In distribution | |
| 1516-20-910 | In distribution | |
| 1518-20-714 | In distribution | |
| 1516-40-416 | In distribution | |
| 1516-40-806 | In distribution | |
| 1520-20-605 | In distribution | |
| 1516-40-714 | In distribution | |
| 1516-40-110 | In distribution | |
| 1516-40-710 | In distribution | |
| 1520-20-214 | In distribution | |
| 1520-20-205 | In distribution | |
| 1518-21-008 | In distribution | |
| 1520-20-414 | In distribution | |
| 1516-40-114 | In distribution | |
| 1516-20-207 | In distribution | |
| 1516-20-508 | In distribution | |
| 1516-20-205 | In distribution | |
| 1516-40-505 | In distribution | |
| 1516-40-812 | In distribution | |
| 1516-20-407 | In distribution | |
| 1518-20-907 | In distribution | |
| 1520-20-708 | In distribution | |
| 1516-20-505 | In distribution | |
| 1516-20-412 | In distribution | |
| 1516-20-307 | In distribution | |
| 1516-20-614 | In distribution | |
| 1520-20-316 | In distribution | |
| 1518-20-407 | In distribution | |
| 1516-20-208 | In distribution | |
| 1516-40-712 | In distribution | |
| 1520-21-010 | In distribution | |
| 1506-00-002 | In distribution | |
| 1518-20-408 | In distribution | |
| 1516-20-805 | In distribution | |
| 1516-40-520 | In distribution | |
| 1516-20-808 | In distribution | |
| 1516-40-605 | In distribution | |
| 1518-20-606 | In distribution | |
| 1516-20-612 | In distribution | |
| 1516-40-116 | In distribution | |
| 1516-40-305 | In distribution | |
| 1516-40-916 | In distribution | |
| 1516-21-005 | In distribution | |
| 1516-41-014 | In distribution | |
| 1516-40-510 | In distribution | |
| 1516-21-006 | In distribution | |
| 1516-21-014 | In distribution | |
| 1516-40-512 | In distribution | |
| 1518-20-314 | In distribution | |
| 1520-20-710 | In distribution | |
| 1516-20-310 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Persona® | Zimmer, Inc. | 552 |
| DJO Surgical | Encore Medical, L.P. | 415 |
| Genflex2 Total Knee System | Globus Medical, Inc. | 389 |
| Persona® Vivacit-E® | Zimmer, Inc. | 332 |
| Truliant, Activit-E | Exactech, Inc. | 272 |
| TriVerse Meniscal Insert PS | Signature Orthopaedics PTY Limited | 220 |
| U2™ Knee | United Orthopedic Corp. | 195 |
| BKS E-Vitalize | Ortho Development Corp. | 193 |
| Vanguard XP Instrumentation | Biomet Orthopedics | 169 |
| Vanguard Complete Knee System | Biomet Orthopedics | 153 |
| EXp Tibial Inserts and Patellar Components | Globus Medical, Inc. | 144 |
| TriVerse Meniscal Insert AS | Signature Orthopaedics PTY Limited | 126 |
Showing 12 of 102. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Recalls Naming This Product
2 recalls name this product by its own identifiers, 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 | 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 |
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.