Fitbone TAA System
Fitbone Intramedullary Lengthening Nail TAA1180-T-245
17manufacturers in China registered for this device type
155catalogue numbers in this listing
14510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (3). 10 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 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 17. All 17 manufacturers in China registered for Rod, Fixation, Intramedullary And Accessories
Record
| Listed by | Orthofix SRL, Italy |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K163368 |
| Record published | 2023-04-14 |
| Record revised | 2025-10-24 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Outer diameter 2 to 16 mm; length 9 to 480 mm; lumen/inner diameter 8 to 15 mm; length 25 to 480 µm; angle 45 to 90 °; outer diameter 4 to 10.5 µm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Outer Diameter 12.5 mm | In distribution |
| 1 | Length 55 µm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Length 40 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Length 60 mm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 14 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Length 35 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Length 70 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 13 mm | In distribution |
| 1 | Outer Diameter 13 mm | In distribution |
| 1 | Outer Diameter 14 mm | In distribution |
| 1 | Outer Diameter 14 mm | In distribution |
| 1 | Length 25 µm | In distribution |
| 1 | Length 105 mm | In distribution |
| 1 | Length 20 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Outer Diameter 15 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 15 mm | In distribution |
| 1 | Length 25 mm | In distribution |
| 1 | Length 65 mm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 40 µm | In distribution |
| 1 | Outer Diameter 15 mm | In distribution |
| 1 | Outer Diameter 11.5 mm | In distribution |
| 1 | Outer Diameter 13 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 14 mm | In distribution |
| 1 | Length 110 mm | In distribution |
| 1 | Length 20 mm | In distribution |
| 1 | Length 95 mm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Lumen/Inner Diameter 15 mm | In distribution |
| 1 | Outer Diameter 16 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 50 mm | In distribution |
| 1 | Length 30 µm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | Outer Diameter 15 mm | In distribution |
| 1 | Length 20 mm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Outer Diameter 14 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 15 mm | In distribution |
| 1 | Outer Diameter 10.5 µm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Outer Diameter 15 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | Angle 45 ° | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Outer Diameter 15 mm | In distribution |
| 1 | Outer Diameter 13 mm | In distribution |
| 1 | Outer Diameter 2 mm | In distribution |
| 1 | Outer Diameter 10 mm | In distribution |
| 1 | Dimension of hexagon nut 17 MM | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Length 280 mm | In distribution |
| 1 | Lumen/Inner Diameter 14 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | Lumen/Inner Diameter 15 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | Angle 90 ° | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | Length 40 mm | In distribution |
| 1 | Outer Diameter 13 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 13 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Lumen/Inner Diameter 12 mm | In distribution |
| 1 | Outer Diameter 8 mm | In distribution |
| 1 | Outer Diameter 13 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Outer Diameter 8 mm | In distribution |
| 1 | Lumen/Inner Diameter 12 mm | In distribution |
| 1 | Length 75 mm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | Outer Diameter 13 mm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | Lumen/Inner Diameter 11 mm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Outer Diameter 16 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | Length 90 µm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Length 100 µm | In distribution |
| 1 | Lumen/Inner Diameter 13 mm | In distribution |
| 1 | Outer Diameter 16 mm | In distribution |
| 1 | Outer Diameter 13 mm | In distribution |
| 1 | Outer Diameter 13 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Outer Diameter 14 mm | In distribution |
| 1 | Length 85 µm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Length 45 mm | In distribution |
| 1 | Outer Diameter 13 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Length 45 mm | In distribution |
| 1 | Outer Diameter 4 mm | In distribution |
| 1 | Length 35 µm | In distribution |
| 1 | Length 25 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 300 mm | In distribution |
| 1 | Outer Diameter 13.5 mm | In distribution |
| 1 | Outer Diameter 13 mm | In distribution |
| 1 | Length 35 mm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 10 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | Length 80 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| T2 | Stryker GmbH | 1,373 |
| Autobahn | Globus Medical, Inc. | 1,258 |
| Gamma | Stryker GmbH | 1,120 |
| Summa Orthopaedics Femur Nail System | Jeil Medical Corporation | 742 |
| Arix Femur Nail System | Jeil Medical Corporation | 742 |
| Orthofix | Orthofix SRL | 721 |
| Rod, Fixation, Intramedullary And Accessories | Synthes Gmbh | 715 |
| Trigen | Smith & Nephew, Inc. | 681 |
| Arthrex® | Arthrex, Inc. | 665 |
| Precice® Intramedullary Limb Lengthening System | NuVasive Specialized Orthopedics, Inc. | 596 |
| Apex | Orthoxel Designated Activity Company | 569 |
| Natural Nail® | Zimmer, Inc. | 552 |
Showing 12 of 2,207. All products under Rod, Fixation, Intramedullary And Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260146 | 2026-05-19 |
| K253991 | 2026-05-08 |
| K250112 | 2025-04-10 |
| K233867 | 2024-06-18 |
| K232648 | 2024-05-03 |
| K232169 | 2024-03-22 |
| K172699 | 2018-04-23 |
| K173458 | 2017-12-07 |
| K161466 | 2017-01-24 |
| K141571 | 2014-11-12 |
| K053261 | 2005-12-12 |
| K031219 | 2003-05-28 |
| K973944 | 1997-12-19 |
| K961027 | 1996-05-08 |
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 |
|---|---|---|---|---|
| 2024-09-24 | Class II | Use error | Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced. | 2 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.