Attune
Attune Knee System FEMORAL POROCOAT CRUCIATE RETAINING NARROW SIZE 3N RIGHT CEMENTLESS
12manufacturers in China registered for this device type
234catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 8 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 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Depuy (Ireland), Ireland |
|---|---|
| FDA product code | MBH |
| Device type | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3565 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K160700 |
| Record published | 2016-12-05 |
| 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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1513-20-160 | In distribution | |
| 1517-00-424 | In distribution | |
| 1517-00-126 | In distribution | |
| 1511-01-106 | In distribution | |
| 1520-20-110 | In distribution | |
| 1512-14-030 | In distribution | |
| 1517-00-116 | In distribution | |
| 1504-40-202 | In distribution | |
| 1547-08-002 | In distribution | |
| 1549-05-002 | In distribution | |
| 1518-20-507 | In distribution | |
| 1504-11-109 | In distribution | |
| 1517-00-412 | In distribution | |
| 1517-00-120 | In distribution | |
| 1520-20-507 | In distribution | |
| 1504-40-207 | In distribution | |
| 1520-20-514 | In distribution | |
| 1506-40-005 | In distribution | |
| 1549-10-002 | In distribution | |
| 1506-40-003 | In distribution | |
| 1517-00-224 | In distribution | |
| 1517-01-022 | In distribution | |
| 1520-20-712 | In distribution | |
| 1504-40-209 | In distribution | |
| 1517-00-222 | In distribution | |
| 1518-20-707 | In distribution | |
| 1504-40-205 | In distribution | |
| 1511-01-103 | In distribution | |
| 1547-09-003 | In distribution | |
| 1547-09-002 | In distribution | |
| 1517-01-006 | In distribution | |
| 1513-02-000 | In distribution | |
| 1518-20-808 | In distribution | |
| 1549-08-002 | In distribution | |
| 1518-20-706 | In distribution | |
| 1504-01-125 | In distribution | |
| 1517-00-212 | In distribution | |
| 1520-20-508 | In distribution | |
| 1517-00-922 | In distribution | |
| 1517-00-324 | In distribution | |
| 1511-06-010 | In distribution | |
| 1506-40-007 | In distribution | |
| 1547-05-003 | In distribution | |
| 1518-20-505 | In distribution | |
| 1520-20-907 | In distribution | |
| 1511-01-104 | In distribution | |
| 1517-00-520 | In distribution | |
| 1513-22-110 | In distribution | |
| 1517-00-418 | In distribution | |
| 1518-20-805 | In distribution | |
| 1506-40-006 | In distribution | |
| 1517-00-526 | In distribution | |
| 1523-05-203 | In distribution | |
| 1504-40-210 | In distribution | |
| 1517-00-312 | In distribution | |
| 1517-00-626 | In distribution | |
| 1520-20-506 | In distribution | |
| 1523-09-102 | In distribution | |
| 1517-00-508 | In distribution | |
| 1504-11-104 | In distribution | |
| 1517-00-524 | In distribution | |
| 1547-02-002 | In distribution | |
| 1513-10-160 | In distribution | |
| 1517-00-122 | In distribution | |
| 1513-22-160 | In distribution | |
| 1517-00-226 | In distribution | |
| 1523-09-202 | In distribution | |
| 1547-07-004 | In distribution | |
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| 1513-18-160 | In distribution | |
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| 1518-20-112 | In distribution | |
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| 1518-20-308 | In distribution | |
| 1523-05-102 | In distribution | |
| 1506-40-009 | In distribution | |
| 1517-00-326 | In distribution | |
| 1517-01-016 | In distribution | |
| 1547-04-001 | In distribution | |
| 1520-20-512 | In distribution | |
| 1517-00-106 | In distribution | |
| 1517-00-924 | In distribution | |
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| 1547-04-002 | In distribution | |
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| 1513-16-110 | In distribution | |
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| 1513-16-160 | In distribution | |
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| 1513-14-160 | In distribution | |
| 1520-20-310 | In distribution | |
| 1547-10-002 | In distribution | |
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| 1504-11-209 | In distribution | |
| 1547-10-004 | In distribution | |
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| 1504-40-104 | In distribution | |
| 1517-01-018 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy | Microport Orthopedics Inc. | 4,272 |
| Triathlon | Howmedica Osteonics Corp | 712 |
| Instrument | Howmedica Osteonics Corp | 709 |
| Persona® Vivacit-E® | Zimmer, Inc. | 499 |
| Arthrex® | Arthrex, Inc. | 494 |
| Persona® | Zimmer, Inc. | 441 |
| Legion | Smith & Nephew, Inc. | 397 |
| U2 Total Knee System | United Orthopedic Corp. | 286 |
| DJO Surgical | Encore Medical, L.P. | 191 |
| Vanguard XP Instrumentation | Biomet Orthopedics | 150 |
| Truliant® | Exactech, Inc. | 142 |
| Vanguard Knee System | Biomet Orthopedics | 125 |
Showing 12 of 948. All products under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140881 | 2015-02-13 |
Recalls Naming This Product
5 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 | 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. | 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 | 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.