Driver, Prosthesis
MTO Retrograde Reamer Locking Shaft
9manufacturers in China registered for this device type
17catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (5), Zhejiang (2), Shanghai (1). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Jiangsu Kersen Medical Instrument Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 3 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | HWR |
| Device type | Driver, Prosthesis |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K921481 |
| Record published | 2015-08-29 |
| Record revised | 2023-10-04 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2023-08-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 111560 | In distribution | |
| 111561 | In distribution | |
| 014815 | In distribution | |
| 72202952 | Withdrawn | |
| 72202953 | Withdrawn | |
| 7207268D | Withdrawn | |
| 69000006 | Withdrawn | |
| 69000008 | Withdrawn | |
| 72202949 | Withdrawn | |
| 72202945 | Withdrawn | |
| 72202948 | Withdrawn | |
| 69000007 | Withdrawn | |
| 72202950 | Withdrawn | |
| 014815D | Withdrawn | |
| 72202951 | Withdrawn | |
| 72202944 | Withdrawn | |
| 69000005 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Driver, Prosthesis | Depuy Spine, Inc. | 270 |
| ACE | Ace Surgical Supply Co., Inc. | 64 |
| Expedium | Medos International Sàrl | 54 |
| Moss | Depuy Spine, Inc. | 33 |
| Acumed | Acumed LLC | 24 |
| Streamline TL Spinal Fixation System | Pioneer Surgical Technology, Inc. | 23 |
| U2 Total Knee System | United Orthopedic Corp. | 23 |
| Driver, Prosthesis | Zimmer, Inc. | 22 |
| Viper | Depuy Spine, Inc. | 21 |
| X-Mesh | Depuy Spine, Inc. | 20 |
| Driver, Prosthesis | Depuy (Ireland) | 18 |
| Invictus | Alphatec Spine, Inc. | 18 |
Showing 12 of 390. All products under Driver, Prosthesis
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 |
|---|---|---|---|---|---|
| 2013-04-04 | Class II | Employee error | Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver. | 157 | 2021-03-22 |
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.