Fixion Nailing System
The nail is intended for use in the fixation of long bone fractures, including diaphyseal fractures. It is indicated for shaft fractures 5cm below the surgical neck, and 5cm proximal to the…
The nail is intended for use in the fixation of long bone fractures, including diaphyseal fractures. It is indicated for shaft fractures 5cm below the surgical neck, and 5cm proximal to the distal end of the medullary canal. Includes nail cap.
17manufacturers in China registered for this device type
180catalogue numbers in this listing
6510(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 | CarboFix Orthopedics, Ltd., Israel |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Manufacturer |
| Record published | 2015-10-15 |
| Record revised | 2026-02-09 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 3.5 to 570 mm; outer diameter 3.2 to 6 mm; angle 125 to 135 ° |
| Distribution end date | 2024-07-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Interlocking Humeral Nail | Length 180 mm | In distribution |
| Nail Cap | Withdrawn | |
| Cortical Screw | Outer Diameter 3.5 mm | Withdrawn |
| Proximal Femur Nail Cap | Length 10 mm | Withdrawn |
| Cortical Screw | Length 40 mm | Withdrawn |
| Interlocking Tibial Nail | Proximal Diameter: 12 Millimeter | Withdrawn |
| Cortical Screw | Length 28 mm | Withdrawn |
| Interlocking Humeral Nail | Proximal Diameter: 10.5 Millimeter | Withdrawn |
| Cortical Screw | Length 44 mm | Withdrawn |
| Proximal Femur Nail | Angle 130 ° | Withdrawn |
| Cortical Screw | Outer Diameter 3.5 mm | Withdrawn |
| Proximal Femur Nail | Right/Left: R | Withdrawn |
| Femoral Nail | Proximal Diameter: 12.4 Millimeter | Withdrawn |
| Cortical Screw | Outer Diameter 6 mm | Withdrawn |
| Femoral Nail | Length 360 mm | Withdrawn |
| Cortical Screw | Length 85 mm | Withdrawn |
| Femoral Nail | Proximal Diameter: 14.5 Millimeter | Withdrawn |
| Interlocking Humeral Nail | Proximal Diameter: 10.5 Millimeter | Withdrawn |
| Proximal Femur Nail | Proximal Diameter: 15.5 Millimeter | Withdrawn |
| Cortical Screw | Outer Diameter 4.5 mm | Withdrawn |
| Tibial Nail | Length 380 mm | Withdrawn |
| Femoral Nail Cap | Withdrawn | |
| Interlocking Humeral Nail | Length 260 mm | Withdrawn |
| Proximal Femur Hip Peg | Length 80 mm | Withdrawn |
| Cortical Screw | Length 35 mm | Withdrawn |
| Tibial Nail | Length 280 mm | Withdrawn |
| Humeral Nail | Length 180 mm | Withdrawn |
| Proximal Femur Nail | Proximal Diameter: 14 Millimeter | Withdrawn |
| Femoral Nail | Proximal Diameter: 10.7 Millimeter | Withdrawn |
| Femoral Nail | Length 400 mm | Withdrawn |
| Interlocking Humeral Nail | Proximal Diameter: 8 Millimeter | Withdrawn |
| Femoral Nail | Length 400 mm | Withdrawn |
| Cortical Screw | Outer Diameter 3.5 mm | Withdrawn |
| Humeral Nail | Length 280 mm | Withdrawn |
| Femoral Nail | Proximal Diameter: 14.5 Millimeter | Withdrawn |
| Tibial Nail | Proximal Diameter: 10.7 Millimeter | Withdrawn |
| Cortical Screw | Outer Diameter 3.5 mm | Withdrawn |
| Tibial Nail | Length 340 mm | Withdrawn |
| Femoral Nail | Proximal Diameter: 10.7 Millimeter | Withdrawn |
| Dual Interlocking Tibial Nail | Proximal Diameter: 10.5 Millimeter | Withdrawn |
| Proximal Femur Hip Peg | Length 100 mm | Withdrawn |
| Tibial Nail | Proximal Diameter: 12.4 Millimeter | Withdrawn |
| Cortical Screw | Length 48 mm | Withdrawn |
| Cortical Screw | Outer Diameter 3.5 mm | Withdrawn |
| Proximal Femur Hip Pin | Outer Diameter 5 mm | Withdrawn |
| Interlocking Femoral Nail | Proximal Diameter: 12 Millimeter | Withdrawn |
| Proximal Femur Nail | Angle 135 ° | Withdrawn |
| Humeral Nail | Length 200 mm | Withdrawn |
| Femoral Nail | Length 360 mm | Withdrawn |
| Tibial Nail | Proximal Diameter: 10.7 Millimeter | Withdrawn |
| Interlocking Humeral Nail | Length 260 mm | Withdrawn |
| Tibial Nail | Length 260 mm | Withdrawn |
| Cortical Screw | Length 55 mm | Withdrawn |
| Tibial Nail | Length 320 mm | Withdrawn |
| Proximal Femur Nail | Right/Left: L | Withdrawn |
| Interlocking Tibial Nail | Proximal Diameter: 10.5 Millimeter | Withdrawn |
| Interlocking Humeral Nail | Length 180 mm | Withdrawn |
| Femoral Nail | Length 320 mm | Withdrawn |
| Interlocking Humeral Nail | Length 220 mm | Withdrawn |
| Interlocking Femoral Nail | Length 340 mm | Withdrawn |
| Humeral Nail | Length 240 mm | Withdrawn |
| Tibial Nail | Proximal Diameter: 10.7 Millimeter | Withdrawn |
| Proximal Femur Nail | Angle 125 ° | Withdrawn |
| K-Wire | Outer Diameter 3.2 mm | Withdrawn |
| Dual Interlocking Tibial Nail | Length 340 mm | Withdrawn |
| Interlocking Humeral Nail | Proximal Diameter: 8 Millimeter | Withdrawn |
| Interlocking Humeral Nail | Proximal Diameter: 8 Millimeter | Withdrawn |
| Proximal Femur Hip Peg | Proximal Diameter: 8 x 10 Millimeter | Withdrawn |
| Femoral Nail | Proximal Diameter: 10.7 Millimeter | Withdrawn |
| Interlocking Tibial Nail | Proximal Diameter: 10.5 Millimeter | Withdrawn |
| Cortical Screw | Length 25 mm | Withdrawn |
| Femoral Nail | Proximal Diameter: 10.7 Millimeter | Withdrawn |
| Interlocking Humeral Nail | Proximal Diameter: 8 Millimeter | Withdrawn |
| Proximal Femur Nail | Angle 135 ° | Withdrawn |
| Tibial Nail Cap | Withdrawn | |
| Interlocking Tibial Nail | Proximal Diameter: 10.5 Millimeter | Withdrawn |
| Cortical Screw | Length 24 mm | Withdrawn |
| Femoral Nail | Proximal Diameter: 12.4 Millimeter | Withdrawn |
| Humeral Nail | Length 220 mm | Withdrawn |
| Femoral Nail | Length 440 mm | Withdrawn |
| Femoral Nail | Proximal Diameter: 12.4 Millimeter | Withdrawn |
| Cortical Screw | Outer Diameter 4.5 mm | Withdrawn |
| Interlocking Femoral Nail | Proximal Diameter: 12 Millimeter | Withdrawn |
| Cortical Screw | Outer Diameter 4.5 mm | Withdrawn |
| Interlocking Femoral Nail | Length 220 mm | Withdrawn |
| Cortical Screw | Outer Diameter 4.5 mm | Withdrawn |
| Femoral Nail | Length 480 mm | Withdrawn |
| Femoral Nail | Length 360 mm | Withdrawn |
| Proximal Femur Nail Cap | Length 3.5 mm | Withdrawn |
| Interlocking Humeral Nail | Proximal Diameter: 8 Millimeter | Withdrawn |
| Dual Interlocking Tibial Nail | Length 300 mm | Withdrawn |
| Femoral Nail | Proximal Diameter: 14.5 Millimeter | Withdrawn |
| Cortical Screw | Length 20 mm | Withdrawn |
| Interlocking Tibial Nail | Proximal Diameter: 10.5 Millimeter | Withdrawn |
| Cortical Screw | Length 52 mm | Withdrawn |
| Femoral Nail | Length 320 mm | Withdrawn |
| Femoral Nail | Length 440 mm | Withdrawn |
| Proximal Femur Hip Peg | Proximal Diameter: 8 x 10 Millimeter | Withdrawn |
| Cortical Screw | Length 36 mm | Withdrawn |
| Cortical Screw | Outer Diameter 3.5 mm | Withdrawn |
| Femoral Nail | Proximal Diameter: 14.5 Millimeter | Withdrawn |
| Cortical Screw | Outer Diameter 3.5 mm | Withdrawn |
| Cortical Screw | Outer Diameter 6 mm | Withdrawn |
| Femoral Nail | Proximal Diameter: 12.4 Millimeter | Withdrawn |
| Cortical Screw | Length 65 mm | Withdrawn |
| Cortical Screw | Length 55 mm | Withdrawn |
| Tibial Nail | Proximal Diameter: 12.4 Millimeter | Withdrawn |
| Proximal Femur Hip Peg | Length 120 mm | Withdrawn |
| Proximal Femur Nail | Right/Left: L | Withdrawn |
| Interlocking Tibial Nail | Length 320 mm | Withdrawn |
| Tibial Nail | Length 300 mm | Withdrawn |
| Proximal Femur Nail | Right/Left: R | Withdrawn |
| Tibial Nail | Length 420 mm | Withdrawn |
| Proximal Femur Nail | Proximal Diameter: 14 Millimeter | Withdrawn |
| Femoral Nail | Length 480 mm | Withdrawn |
| Tibial Nail | Proximal Diameter: 12.4 Millimeter | Withdrawn |
| Interlocking Tibial Nail | Proximal Diameter: 10.5 Millimeter | Withdrawn |
| Proximal Femur Nail | Angle 125 ° | Withdrawn |
| Humeral Nail | Length 300 mm | Withdrawn |
| Tibial Nail | Proximal Diameter: 12.4 Millimeter | Withdrawn |
| Femoral Nail | Proximal Diameter: 10.7 Millimeter | Withdrawn |
| Interlocking Humeral Nail | Length 220 mm | Withdrawn |
| Tibial Nail | Length 400 mm | Withdrawn |
| Cortical Screw | Length 16 mm | Withdrawn |
| Tibial Nail | Length 420 mm | Withdrawn |
| Interlocking Tibial Nail | Length 280 mm | Withdrawn |
| Cortical Screw | Length 45 mm | Withdrawn |
| Interlocking Tibial Nail | Length 400 mm | Withdrawn |
| Cortical Screw | Outer Diameter 6 mm | Withdrawn |
| Cortical Screw | Outer Diameter 4.5 mm | Withdrawn |
| Humeral Nail | Length 280 mm | Withdrawn |
| Femoral Nail | Length 440 mm | Withdrawn |
| Cortical Screw | Outer Diameter 3.5 mm | Withdrawn |
| Proximal Femur Nail | Right/Left: L | Withdrawn |
| Cortical Screw | Outer Diameter 3.5 mm | Withdrawn |
| Femoral Nail | Length 320 mm | Withdrawn |
| Femoral Nail | Proximal Diameter: 12.4 Millimeter | Withdrawn |
| Femoral Nail | Length 480 mm | Withdrawn |
| Interlocking Humeral Nail | Length 220 mm | Withdrawn |
| Proximal Femur Nail | Right/Left: R | Withdrawn |
| Dual Interlocking Tibial Nail | Proximal Diameter: 10.5 Millimeter | Withdrawn |
| Cortical Screw | Outer Diameter 4.5 mm | Withdrawn |
| Humeral Nail Cap | Withdrawn | |
| Proximal Femur Nail | Proximal Diameter: 14 Millimeter | Withdrawn |
| Cortical Screw | Length 85 mm | Withdrawn |
| Tibial Nail | Proximal Diameter: 10.7 Millimeter | Withdrawn |
| Cortical Screw | Outer Diameter 6 mm | Withdrawn |
| Proximal Femur Hip Pin | Length 100 mm | Withdrawn |
| Interlocking Femoral Nail | Length 260 mm | Withdrawn |
| Femoral Nail | Proximal Diameter: 14.5 Millimeter | Withdrawn |
| Cortical Screw | Outer Diameter 6 mm | Withdrawn |
| Cortical Screw | Length 75 mm | Withdrawn |
| Humeral Nail | Length 260 mm | Withdrawn |
| Cortical Screw | Outer Diameter 4.5 mm | Withdrawn |
| Cortical Screw | Length 52 mm | Withdrawn |
| Cortical Screw | Length 56 mm | Withdrawn |
| Cortical Screw | Length 65 mm | Withdrawn |
| Cortical Screw | Outer Diameter 3.5 mm | Withdrawn |
| Cortical Screw | Outer Diameter 3.5 mm | Withdrawn |
| Femoral Nail | Length 400 mm | Withdrawn |
| Cortical Screw | Length 75 mm | Withdrawn |
| Proximal Femur Nail Cap | Length 20 mm | Withdrawn |
| Interlocking Humeral Nail | Length 260 mm | Withdrawn |
| Proximal Femur Hip Pin | Length 70 mm | Withdrawn |
| Interlocking Femoral Nail | Proximal Diameter: 12 Millimeter | Withdrawn |
| Tibial Nail | Proximal Diameter: 12.4 Millimeter | Withdrawn |
| Cortical Screw | Outer Diameter 6 mm | Withdrawn |
| Cortical Screw | Length 60 mm | Withdrawn |
| Cortical Screw | Length 32 mm | Withdrawn |
| Interlocking Humeral Nail | Length 180 mm | Withdrawn |
| Tibial Nail | Length 360 mm | Withdrawn |
| Cortical Screw | Outer Diameter 3.5 mm | Withdrawn |
| Interlocking Humeral Nail | Proximal Diameter: 10.5 Millimeter | Withdrawn |
| Humeral Nail | Length 200 mm | Withdrawn |
| Proximal Femur Hip Pin | Outer Diameter 5 mm | Withdrawn |
| Proximal Femur Hip Pin | Outer Diameter 5 mm | Withdrawn |
| Proximal Femur Nail | Proximal Diameter: 14 Millimeter | Withdrawn |
| Humeral Nail | Length 240 mm | Withdrawn |
| Interlocking Humeral Nail | Proximal Diameter: 8 Millimeter | Withdrawn |
| Interlocking Tibial Nail | Length 360 mm | Withdrawn |
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 |
|---|---|
| K173652 | 2017-12-28 |
| K153536 | 2016-01-06 |
| K151010 | 2015-07-28 |
| K132774 | 2013-10-03 |
| K123810 | 2013-06-14 |
| K111056 | 2011-05-03 |
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 |
|---|---|---|---|---|---|
| 2016-05-10 | Class II | Other | Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility. | 638 | 2017-01-27 |
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.