Stainless Steel Femoral Nailing System
Stainless Steel Femoral Nailing System: 196 catalogue numbers listed by Orthofix SRL, Italy, under Rod, Fixation, Intramedullary And Accessories. 17 manufacturers in China are registered for this product code.
17manufacturers in China registered for this device type
196catalogue 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 |
| Record published | 2018-04-10 |
| Record revised | 2025-10-24 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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 3 to 15 mm; length 30 to 980 mm; width 34 to 124 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 980 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 35 mm | In distribution |
| 1 | Length 40 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 60 mm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | Length 60 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 380 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Length 340 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Length 90 mm | In distribution |
| 1 | Width 36 mm | In distribution |
| 1 | Outer Diameter 10 mm | In distribution |
| 1 | Length 440 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | Outer Diameter 10 mm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Length 65 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | Width 124 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 10 mm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 420 mm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Length 440 mm | In distribution |
| 1 | Length 420 mm | In distribution |
| 1 | Length 90 mm | In distribution |
| 1 | Length 360 mm | In distribution |
| 1 | Length 340 mm | In distribution |
| 1 | Length 440 mm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Length 300 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Outer Diameter 14 mm | In distribution |
| 1 | Length 480 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | Length 400 mm | In distribution |
| 1 | Length 360 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 280 mm | In distribution |
| 1 | Outer Diameter 10.5 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 50 mm | In distribution |
| 1 | Outer Diameter 13.5 mm | In distribution |
| 1 | Outer Diameter 13 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 85 mm | In distribution |
| 1 | Outer Diameter 10 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Length 280 mm | In distribution |
| 1 | Outer Diameter 14.5 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 320 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 10 mm | In distribution |
| 1 | Length 440 mm | In distribution |
| 1 | Length 400 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 80 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 480 mm | In distribution |
| 1 | Length 75 mm | In distribution |
| 1 | Length 380 mm | In distribution |
| 1 | Length 55 mm | In distribution |
| 1 | Length 45 mm | In distribution |
| 1 | THREAD DIAMETER 6 MM | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Length 320 mm | In distribution |
| 1 | Length 460 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Length 360 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Outer Diameter 10 mm | In distribution |
| 1 | Width 122 mm | In distribution |
| 1 | Length 380 mm | In distribution |
| 1 | Length 340 mm | In distribution |
| 1 | Length 420 mm | In distribution |
| 1 | Length 105 mm | In distribution |
| 1 | Length 400 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Length 110 mm | In distribution |
| 1 | Length 105 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Length 310 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 980 mm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Length 320 mm | In distribution |
| 1 | Length 420 mm | In distribution |
| 1 | Outer Diameter 10 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 380 mm | In distribution |
| 1 | Outer Diameter 15 mm | In distribution |
| 1 | Outer Diameter 10 mm | In distribution |
| 1 | Outer Diameter 11.5 mm | In distribution |
| 1 | Length 340 mm | In distribution |
| 1 | Outer Diameter 9.5 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 440 mm | In distribution |
| 1 | Length 70 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Length 400 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Length 95 mm | In distribution |
| 1 | Length 440 mm | In distribution |
| 1 | Outer Diameter 12.5 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 280 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | Length 280 mm | In distribution |
| 1 | Outer Diameter 8 mm | In distribution |
| 1 | Length 420 mm | In distribution |
| 1 | Length 50 mm | In distribution |
| 1 | Outer Diameter 10 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Length 70 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 460 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 280 mm | In distribution |
| 1 | Length 360 mm | In distribution |
| 1 | Length 360 mm | In distribution |
| 1 | Length 380 mm | In distribution |
| 1 | Length 460 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 400 mm | In distribution |
| 1 | Length 80 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 12 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 380 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 320 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Outer Diameter 8 mm | In distribution |
| 1 | Outer Diameter 10 mm | In distribution |
| 1 | Width 123 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 34 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 360 mm | In distribution |
| 1 | Length 460 mm | In distribution |
| 1 | Outer Diameter 11 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 340 mm | In distribution |
| 1 | Length 420 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | Outer Diameter 10 mm | In distribution |
| 1 | Outer Diameter 4 mm | In distribution |
| 1 | THREAD DIAMETER 4 MM | In distribution |
| 1 | In distribution | |
| 1 | Length 40 mm | In distribution |
| 1 | Length 35 mm | In distribution |
| 1 | Length 300 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.