Trabecular Metal®
37 catalogue numbers from 00-4312-014-00, listed by Zimmer, Inc., United States, under Reamer. 23 manufacturers in China are registered for this product code.
23manufacturers in China registered for this device type
37catalogue numbers in this listing
1510(k) clearance
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 | Zimmer, Inc., United States |
|---|---|
| FDA product code | HTO |
| Device type | Reamer |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-08-15 |
| Record revised | 2023-10-04 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-4312-014-00 | 14 mm Diameter | In distribution |
| 00-7865-010-14 | Size 14 | In distribution |
| 82-0156-870-03 | Diameter 46mm – Diameter 34mm | In distribution |
| 00-4312-008-00 | 8 mm Diameter | In distribution |
| 00-7865-010-11 | Size 11 | In distribution |
| 82-0156-870-00 | Diameter 31mm – Diameter 31mm | In distribution |
| 82-0156-870-06 | Diameter 60mm – Diameter 36mm – Left | In distribution |
| SSI004082 | Diameter 48mm – Diameter 15mm – X-Small | In distribution |
| 82-0156-870-08 | Diameter 51mm – Diameter 34mm – Right | In distribution |
| 00-4312-012-00 | 12 mm Diameter | In distribution |
| 00-7865-010-17 | Size 17 | In distribution |
| 00-7865-010-12 | Size 12 | In distribution |
| 00-7865-010-13 | Size 13 | In distribution |
| 82-0156-870-10 | Diameter 60mm – Diameter 36mm – Right | In distribution |
| 00-4312-011-00 | 11 mm Diameter | In distribution |
| 00-4312-010-00 | 10 mm Diameter | In distribution |
| SSI004084 | Diameter 59mm – Diameter 15mm – Medium | In distribution |
| SSI004085 | Diameter 67mm – Diameter 15mm – Large | In distribution |
| 82-0156-870-20 | In distribution | |
| 00-4312-016-00 | 16 mm Diameter | In distribution |
| 82-0156-870-05 | Diameter 55mm – Diameter 36mm – Left | In distribution |
| 00-4312-009-00 | 9 mm Diameter | In distribution |
| 00-7865-010-15 | Size 15 | In distribution |
| 82-0156-870-01 | Diameter 36mm – Diameter 31mm | In distribution |
| 00-4312-013-00 | 13 mm Diameter | In distribution |
| 00-7865-010-18 | Size 18 | In distribution |
| 82-0156-870-09 | Diameter 55mm – Diameter 36mm – Right | In distribution |
| SSI004083 | Diameter 52mm – Diameter 15mm – Small | In distribution |
| 82-0156-870-11 | Diameter 67mm – Diameter 38mm – Right | In distribution |
| 00-7865-010-09 | Size 9 | In distribution |
| 00-7865-010-16 | Size 16 | In distribution |
| 82-0156-870-07 | Diameter 57mm – Diameter 38mm – Left | In distribution |
| 00-7865-010-10 | Size 10 | In distribution |
| 82-0156-870-04 | Diameter 51mm – Diameter 34mm – Left | In distribution |
| 82-0156-870-02 | Diameter 41mm – Diameter 34mm | In distribution |
| 82-0156-870-30 | In distribution | |
| 00-4312-015-00 | 15 mm Diameter | 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 |
| DJO Surgical | Encore Medical, L.P. | 108 |
| Arthrex® | Arthrex, Inc. | 105 |
Showing 12 of 1,224. All products under Reamer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K954915 | 1995-12-28 |
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 |
|---|---|---|---|---|
| 2022-12-07 | Class II | Process control | Two planers were found to be unusable during sawbones shoulder training. | 84 units |
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.