Fitbone Trochanteric
Fitbone Trochanteric is an implantable nail for lengthening the femur. It is placed inside the bone’s medullary canal and secured with locking screws. It is indicated for adults and…
Fitbone Trochanteric is an implantable nail for lengthening the femur. It is placed inside the bone’s medullary canal and secured with locking screws. It is indicated for adults and pediatric patients older than 12 years.
A motor inside the nail separates its telescoping sections. An external transmitter sends electromagnetic energy to an implanted receiver, which converts that energy to electrical power for the motor. A feed line connects the receiver to the nail.
Listed Item
Fitbone Trochanteric Nail L217MM D11MM Sterile
Treatment Setting
Implantation and removal require healthcare professionals familiar with the orthopedic procedure. Distraction can be activated at home or in a clinic using the external control system. The nail is supplied sterile; trial nails are separate surgical accessories.
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) | K250112 |
| Record published | 2025-06-24 |
| Record revised | 2025-10-24 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Outer diameter 9 to 11 mm; length 217 to 357 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Length 357 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | Length 257 mm | In distribution |
| 1 | Length 317 mm | In distribution |
| 1 | Length 317 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Length 277 mm | In distribution |
| 1 | Length 297 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | Length 237 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | Length 217 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Length 297 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | Length 237 mm | In distribution |
| 1 | Outer Diameter 9 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 | Outer Diameter 9 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | Length 317 mm | In distribution |
| 1 | Length 337 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | Length 337 mm | In distribution |
| 1 | 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.