DJO Surgical
Special, AltiVate Anatomic Cannulated Ream-Run Reamer, Sz 40
23manufacturers in China registered for this device type
108catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (6), Zhejiang (3). 8 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| 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 |
| Changzhou Master Precision Tool Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Showing 12 of 23. All 23 manufacturers in China registered for Reamer
Record
| Listed by | Encore Medical, L.P., United States |
|---|---|
| FDA product code | HTO |
| Device type | Reamer |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K161610 |
| Record published | 2024-06-24 |
| Record revised | 2026-04-17 (version 11) |
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, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 414852 | In distribution | |
| S-201115 | In distribution | |
| 804-09-036 | In distribution | |
| S-201093 | In distribution | |
| S-201096 | In distribution | |
| S-201113 | In distribution | |
| 804-03-014 | In distribution | |
| 803-95-017 | In distribution | |
| 804-03-012 | In distribution | |
| 804-06-024 | In distribution | |
| 804-25-049 | In distribution | |
| 804-06-024 | In distribution | |
| 801-05-046 | In distribution | |
| 800-07-046 | In distribution | |
| 414856 | In distribution | |
| 803-95-014 | In distribution | |
| 803-95-012 | In distribution | |
| 804-06-017 | In distribution | |
| 414891 | In distribution | |
| S-201880 | In distribution | |
| 804-03-013 | In distribution | |
| 804-06-019 | In distribution | |
| 804-06-026 | In distribution | |
| 804-09-035 | In distribution | |
| 803-95-005 | In distribution | |
| 803-95-020 | In distribution | |
| 804-06-026 | In distribution | |
| 804-06-030 | In distribution | |
| 801-05-079 | In distribution | |
| 804-09-037 | In distribution | |
| 801-01-018 | In distribution | |
| 801-05-048 | In distribution | |
| 414851 | In distribution | |
| 803-95-015 | In distribution | |
| 804-06-020 | In distribution | |
| 800-07-011 | In distribution | |
| 800-07-047 | In distribution | |
| 804-06-025 | In distribution | |
| S-201114 | In distribution | |
| 803-06-013 | In distribution | |
| 803-50-001 | In distribution | |
| 414912 | In distribution | |
| 804-06-015 | In distribution | |
| S-201111 | In distribution | |
| 414913 | In distribution | |
| 804-06-006 | In distribution | |
| 804-06-016 | In distribution | |
| 804-25-050 | In distribution | |
| S-201092 | In distribution | |
| 804-25-048 | In distribution | |
| 804-06-028 | In distribution | |
| 804-06-008 | In distribution | |
| 803-95-016 | In distribution | |
| 803-95-027 | In distribution | |
| S-201112 | In distribution | |
| 801-05-013 | In distribution | |
| 804-06-016 | In distribution | |
| 803-95-025 | In distribution | |
| 804-09-034 | In distribution | |
| 804-25-047 | In distribution | |
| 803-95-011 | In distribution | |
| 804-06-022 | In distribution | |
| S-201095 | In distribution | |
| 803-95-022 | In distribution | |
| 803-06-008 | In distribution | |
| 804-25-051 | In distribution | |
| 804-06-005 | In distribution | |
| 801-04-020 | In distribution | |
| 803-95-028 | In distribution | |
| 801-05-047 | In distribution | |
| 803-02-046 | In distribution | |
| 803-95-018 | In distribution | |
| S-201882 | In distribution | |
| S-201881 | In distribution | |
| 803-06-012 | In distribution | |
| 803-95-023 | In distribution | |
| 414854 | In distribution | |
| S-201757 | In distribution | |
| 803-06-014 | In distribution | |
| 803-95-021 | In distribution | |
| 803-95-019 | In distribution | |
| 803-95-024 | In distribution | |
| 414855 | In distribution | |
| S-201110 | In distribution | |
| 803-95-026 | In distribution | |
| 801-05-043 | In distribution | |
| 803-06-011 | In distribution | |
| 803-06-010 | In distribution | |
| 804-03-011 | In distribution | |
| 804-06-015 | In distribution | |
| S-201883 | In distribution | |
| 804-03-015 | In distribution | |
| 804-06-018 | In distribution | |
| 804-06-020 | In distribution | |
| S-201094 | In distribution | |
| S-201098 | In distribution | |
| 414890 | In distribution | |
| 804-06-018 | In distribution | |
| 803-95-013 | In distribution | |
| S-201109 | In distribution | |
| 803-06-009 | In distribution | |
| 804-06-022 | In distribution | |
| 804-06-021 | In distribution | |
| 414853 | In distribution | |
| S-201097 | In distribution | |
| S-201884 | In distribution | |
| 804-02-013 | In distribution | |
| 804-06-023 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trigen | Smith & Nephew, Inc. | 1,029 |
| Viant Medical, LLC | Viant Medical, LLC | 825 |
| R3 | Smith & Nephew, Inc. | 287 |
| Reamer | Ortho Development Corp. | 259 |
| InSitu Hip System | Nextstep Arthropedix | 181 |
| Apex Knee System | Omni Life Science, Inc. | 162 |
| Reamer | Synthes Gmbh | 152 |
| Reclaim | Depuy (Ireland) | 138 |
| Reamer | Zimmer, Inc. | 135 |
| Endo-Model Knee System – Instruments | Waldemar Link GmbH & Co. KG | 109 |
| Arthrex® | Arthrex, Inc. | 105 |
| Arthrex | Provision | 98 |
Showing 12 of 1,224. All products under Reamer
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2017-08-04 | Class II | Employee error | It was reported that the models used to manufacture S-200956/958 had the wrong dimension used to create the spherical radius cutting surface. Device design allows a larger spherical radius cutting surface than intended. | 5 units | 2023-06-28 |
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.