Attune
Attune Knee System Revision Cone Large / X-Large Concentric Impactor
18manufacturers in China registered for this device type
31catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (4), Shandong (2). 7 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 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Showing 12 of 18. All 18 manufacturers in China registered for Impactor
Record
| Listed by | Depuy (Ireland), Ireland |
|---|---|
| FDA product code | HWA |
| Device type | Impactor |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-30 |
| Record revised | 2026-02-09 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2524-20-109 | In distribution | |
| 2524-10-112 | In distribution | |
| 2524-10-114 | In distribution | |
| 2545-06-017 | In distribution | |
| 254603333 | In distribution | |
| 2524-10-116 | In distribution | |
| 2544-01-003 | In distribution | |
| 2546-00-424 | In distribution | |
| 2524-10-115 | In distribution | |
| 2544-11-003 | In distribution | |
| 2544-01-009 | In distribution | |
| 2524-00-109 | In distribution | |
| 2524-10-118 | In distribution | |
| 2524-00-105 | In distribution | |
| 2544-01-006 | In distribution | |
| 2546-00-416 | In distribution | |
| 2524-20-108 | In distribution | |
| 2546-00-516 | In distribution | |
| 2544-01-004 | In distribution | |
| 2524-00-107 | In distribution | |
| 254603332 | In distribution | |
| 2544-91-003 | In distribution | |
| 2544-91-004 | In distribution | |
| 2524-00-108 | In distribution | |
| 2544-91-002 | In distribution | |
| 2544-91-001 | In distribution | |
| 2524-10-119 | In distribution | |
| 2524-10-113 | In distribution | |
| 2524-10-117 | In distribution | |
| 2524-00-106 | In distribution | |
| 2544-01-017 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| R3 | Smith & Nephew, Inc. | 153 |
| Conserve® | Microport Orthopedics Inc. | 76 |
| DJO Surgical | Encore Medical, L.P. | 73 |
| Impactor | Synthes Gmbh | 56 |
| Innomed, Inc. | Innomed, Inc. | 53 |
| Impactor | Zimmer, Inc. | 50 |
| Impactor | Zimmer Trabecular Metal Technology, Inc. | 43 |
| iNSitu™ Hip System | Nextstep Arthropedix | 41 |
| Apex Knee System | Omni Life Science, Inc. | 40 |
| DJO Surgical | DJO, LLC | 36 |
| Evolution® | Microport Orthopedics Inc. | 35 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 35 |
Showing 12 of 825. All products under Impactor
Recalls Naming This Product
4 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Depuy Orthopaedics, Inc. | UDI-DI | 2014-11-10 | Class II | Device Design | ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the ins | 4555 | 2015-12-08 |
| Depuy Orthopaedics, Inc. | UDI-DI | 2014-11-10 | Class II | Device Design | ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the ins | 3861 | 2015-12-08 |
| Depuy Orthopaedics, Inc. | UDI-DI | 2014-11-10 | Class II | Device Design | ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the ins | 4661 | 2015-12-08 |
| Depuy Orthopaedics, Inc. | UDI-DI | 2014-11-10 | Class II | Device Design | Complaints have indicated that the ATTUNE INTUITION Impaction Handle lever has fractured during impaction. If the lever fractures, there is the potential for fractured pieces of the device, or the inner spring, if released, to be left in th | 7,944 | 2015-12-08 |
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.