DJO Surgical
EMP Rev Knee, Symmetric Cone, Impactor Head, Femoral, LG
18manufacturers in China registered for this device type
73catalogue numbers in this listing
5recalls on this code
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 | Encore Medical, L.P., United States |
|---|---|
| FDA product code | HWA |
| Device type | Impactor |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K171991 |
| Record published | 2024-06-11 |
| Record revised | 2026-02-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 803-04-236 | In distribution | |
| 804-02-068 | In distribution | |
| 800-07-256 | In distribution | |
| 803-05-131 | In distribution | |
| 800-01-395 | In distribution | |
| 803-04-228 | In distribution | |
| 800-07-247 | In distribution | |
| S-201928 | In distribution | |
| 414924 | In distribution | |
| 801-03-051 | In distribution | |
| 800-04-083 | In distribution | |
| 803-15-002 | In distribution | |
| 800-07-245 | In distribution | |
| 803-04-234 | In distribution | |
| 801-07-146 | In distribution | |
| 804-02-036 | In distribution | |
| 803-04-238 | In distribution | |
| 803-03-245 | In distribution | |
| 803-05-348 | In distribution | |
| 803-15-003 | In distribution | |
| 800-07-246 | In distribution | |
| S-201939 | In distribution | |
| 803-61-031 | In distribution | |
| 803-03-246 | In distribution | |
| 801-07-147 | In distribution | |
| 803-03-303 | In distribution | |
| 801-05-041 | In distribution | |
| S-201861 | In distribution | |
| 801-01-019 | In distribution | |
| 800-03-021 | In distribution | |
| 801-03-039 | In distribution | |
| 801-01-043 | In distribution | |
| 803-15-103 | In distribution | |
| 801-07-145 | In distribution | |
| S-201769 | In distribution | |
| 803-95-002 | In distribution | |
| 800-01-311 | In distribution | |
| 801-06-077 | In distribution | |
| 801-04-049 | In distribution | |
| 800-07-356 | In distribution | |
| 800-06-009 | In distribution | |
| 803-15-101 | In distribution | |
| 803-15-001 | In distribution | |
| 803-03-244 | In distribution | |
| 803-11-103 | In distribution | |
| 801-01-177 | In distribution | |
| 801-06-019 | In distribution | |
| 414894 | In distribution | |
| S-201773 | In distribution | |
| 803-03-304 | In distribution | |
| 803-04-244 | In distribution | |
| 803-04-240 | In distribution | |
| 803-03-305 | In distribution | |
| 804-03-001 | In distribution | |
| 803-73-147 | In distribution | |
| 801-05-030 | In distribution | |
| 804-02-002 | In distribution | |
| 803-03-243 | In distribution | |
| 801-04-048 | In distribution | |
| 801-07-144 | In distribution | |
| 801-03-052 | In distribution | |
| 803-04-232 | In distribution | |
| S-201860 | In distribution | |
| 801-05-065 | In distribution | |
| 803-05-337 | In distribution | |
| 800-01-400 | In distribution | |
| 803-61-032 | In distribution | |
| 414927 | In distribution | |
| 803-15-109 | In distribution | |
| 801-03-040 | In distribution | |
| 803-00-041 | In distribution | |
| 804-02-037 | In distribution | |
| 804-03-051 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| R3 | Smith & Nephew, Inc. | 153 |
| Conserve® | Microport Orthopedics Inc. | 76 |
| 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 |
| Attune | Depuy (Ireland) | 31 |
Showing 12 of 825. All products under Impactor
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Encore Medical, L.P. | 510(k) number | 2022-12-22 | Class II | Labeling Change Control | Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If the incorrect labeling is identified this could lead to surgical delay and if the surgeon does not recognize the size discrepancy between the in | 216 |
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-02-09 | Class II | Device Design | During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating. | 297 units | 2017-10-20 |
| 2017-02-09 | Class II | Device Design | During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating. | 626 units | 2017-10-20 |
| 2015-09-14 | Class II | Device Design | During the assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating. | 634 units | 2016-11-04 |
| 2015-09-14 | Class II | Device Design | During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer form the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating. | 277 units | 2016-11-04 |
| 2007-08-09 | Not classified | Device Design | Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site. | 5 units. | 2008-03-10 |
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.