OsteoBridge™ Idsf Diaphysis Femoral Nail
The OsteoBridge IDSF femoral nail is an implant component for reconstructing major defects in the shaft of the femur after bone loss or resection associated with tumors or metastases. It…
The OsteoBridge IDSF femoral nail is an implant component for reconstructing major defects in the shaft of the femur after bone loss or resection associated with tumors or metastases. It forms part of a modular system for long-term stabilization in oncology patients.
Two intramedullary nails support a spacer across the defect. The spacer’s two cylindrical half-shells clamp over the nail ends with screws. Nail and spacer sizes are chosen for the remaining bone canal and defect. The nails can be fixed with or without cement.
Material and Supply
The implanted components are made from Ti-6Al-4V ELI titanium alloy and supplied sterile. The system is restricted to the diaphyseal region of the bone.
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 | Merete Gmbh, Germany |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K181026 |
| Record published | 2018-10-31 |
| Record revised | 2025-06-23 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 10 to 20 mm; length 60 to 200 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12 90 | Outer Diameter 12 mm | In distribution |
| 14 90 | Outer Diameter 14 mm | In distribution |
| 16 130 | Outer Diameter 16 mm | In distribution |
| 18 90 | Outer Diameter 18 mm | In distribution |
| 10 110 | Outer Diameter 10 mm | In distribution |
| 18 110 | Outer Diameter 18 mm | In distribution |
| 14 200 | Outer Diameter 14 mm | In distribution |
| 14 130 | Outer Diameter 14 mm | In distribution |
| 12 130 | Outer Diameter 12 mm | In distribution |
| 16 200 | Outer Diameter 16 mm | In distribution |
| 10 130 | Outer Diameter 10 mm | In distribution |
| 20 110 | Outer Diameter 20 mm | In distribution |
| 10 70 | Outer Diameter 10 mm | In distribution |
| 14 150 | Outer Diameter 14 mm | In distribution |
| 16 150 | Outer Diameter 16 mm | In distribution |
| 12 70 | Outer Diameter 12 mm | In distribution |
| 10 90 | Outer Diameter 10 mm | In distribution |
| 10 60 | Outer Diameter 10 mm | In distribution |
| 12 150 | Outer Diameter 12 mm | In distribution |
| 14 110 | Outer Diameter 14 mm | In distribution |
| 12 110 | Outer Diameter 12 mm | In distribution |
| 16 110 | Outer Diameter 16 mm | In distribution |
| 20 90 | Outer Diameter 20 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 |
|---|---|
| K181026 | 2018-10-17 |
| K142451 | 2015-02-09 |
| K120978 | 2012-05-02 |
| K113303 | 2011-12-09 |
| K101939 | 2010-10-07 |
| K051965 | 2006-06-16 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Merete Gmbh | 510(k) number | 2020-09-18 | Class II | Process design | Product may be mislabeled. | 354 units | 2021-05-13 |
| Merete Gmbh | 510(k) number | 2020-09-18 | Class II | Process design | Product may be mislabeled. | 215 units | 2021-05-13 |
| Merete Gmbh | 510(k) number | 2020-09-18 | Class II | Process design | Product may be mislabeled. | 144 units | 2021-05-13 |
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 |
|---|---|---|---|---|---|
| 2020-09-18 | Class II | Process design | Product may be mislabeled. | 306 units | 2021-05-13 |
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.