Centronail Titanium Universal Femoral Nailing System
Centronail Titanium Universal Femoral Nailing System: 78 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
78catalogue 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 | Length 0 to 980 mm; outer diameter 3 to 12 mm; width 26 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 30 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 115 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 75 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 50 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 95 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 980 mm | In distribution |
| 1 | Length 400 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 300 mm | In distribution |
| 1 | Outer Diameter 9 mm | In distribution |
| 1 | Length 0 mm | In distribution |
| 1 | Length 375 mm | In distribution |
| 1 | Length 450 mm | In distribution |
| 1 | Length 70 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 350 mm | In distribution |
| 1 | Outer Diameter 6 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 450 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 26 mm | In distribution |
| 1 | Length 110 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 85 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 105 mm | In distribution |
| 1 | Length 35 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 350 mm | In distribution |
| 1 | Length 45 mm | In distribution |
| 1 | Length 65 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 90 mm | In distribution |
| 1 | Length 275 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 425 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 80 mm | In distribution |
| 1 | Length 980 mm | In distribution |
| 1 | In distribution | |
| 1 | Length 55 mm | In distribution |
| 1 | Length 325 mm | In distribution |
| 1 | Length 400 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 105 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Length 40 mm | In distribution |
| 1 | Length 55 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | 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.