TenoTac Soft Tissue Fixation System
K-Wire, Single Ended Trocar Tip, SMOOTH, 0.9 x 100mm
9manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (3), Fujian (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Aplus (Guangzhou) Medical Technology Company | Guangzhou | Guangdong | Contract manufacturer | 6 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Suzhou Endophix Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 17 |
| Changzhou Xietong Industries Co., Ltd. | Changzhou | Jiangsu | Exporter | 11 |
| Changzhou Centrau Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
Record
| Listed by | Paragon 28, United States |
|---|---|
| FDA product code | HXI |
| Device type | Passer, Wire, Orthopedic |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-10-17 |
| Record revised | 2025-09-23 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| P99-192-0910 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vilex Guidewire | Vilex IN Tennessee, Inc. | 51 |
| Baby Gorilla/Gorilla Plating System | Paragon 28 | 33 |
| Monster Screw System | Paragon 28 | 20 |
| Vilex Power Accessory | Vilex IN Tennessee, Inc. | 17 |
| Passer, Wire, Orthopedic | Integrity Implants, Inc. | 16 |
| In2Bones | IN2BONES USA, LLC | 14 |
| endophix | Suzhou Endophix Co., Ltd. | 14 |
| LineSider | Highridge Medical, LLC | 13 |
| Flower Orthopedics | Flower Orthopedics Corporation | 13 |
| Integra® | Ascension Orthopedics, Inc. | 12 |
| Capture™ | Ascension Orthopedics, Inc. | 11 |
| Titanex | Vilex LLC | 10 |
Showing 12 of 171. All products under Passer, Wire, Orthopedic
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 |
|---|---|---|---|---|
| 2026-06-17 | Class II | Under Investigation by firm | Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging. | 514 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.