OsteoBridge™ Idsf Diaphysis
The OsteoBridge IDSF femoral spacer connector joins two spacers in a modular implant used to stabilize major defects in the shaft of the femur. The system is intended for bone loss or…
The OsteoBridge IDSF femoral spacer connector joins two spacers in a modular implant used to stabilize major defects in the shaft of the femur. The system is intended for bone loss or resection associated with tumors or metastases in oncology patients.
When the defect exceeds 70 mm, two spacers can be linked using a spacer connector. The surrounding system uses cylindrical spacer half-shells that clamp over the ends of intramedullary nails. The connector forms part of this assembled bridge across the missing segment of bone.
Listed Item
Femoral Spacer Connector 34 Connection D: 16 TiAl6V4 ELI sterile
Material and Supply
The implant components are made from Ti-6Al-4V ELI titanium alloy and are supplied sterile. The system is restricted to diaphyseal defects; this item is the implanted spacer connector.
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 | 2025-06-20 (version 3) |
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 14 mm; outer diameter 16 µm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14 | Outer Diameter 14 mm | In distribution |
| 16 | Outer Diameter 16 µm | In distribution |
| 10 | Outer Diameter 10 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.