Agile Nail
Agile Nail is an antegrade intramedullary fixation system for the femur. It combines a nail, end caps and screws with instruments for inserting and extracting the implanted components. The…
Agile Nail is an antegrade intramedullary fixation system for the femur. It combines a nail, end caps and screws with instruments for inserting and extracting the implanted components.
The nail is placed in the femoral medullary canal to align and stabilize fractures or support correction of deformity. Screws and end caps complete the internal fixation assembly.
Listed Item
Agile Nail Sterilization BOX Extraction Complete
Anatomical and Patient Scope
The system covers subtrochanteric and femoral-shaft fractures in pediatric patients other than newborns and infants, and adults with a suitable medullary canal. It also has specified applications in osteotomy fixation, nonunion or malunion, reconstruction after tumor resection, and bone lengthening or shortening.
17manufacturers in China registered for this device type
148catalogue 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 |
| 510(k) | K172699 |
| Record published | 2018-05-08 |
| Record revised | 2025-10-24 (version 9) |
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 |
| Sizes | Width 14 to 118 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Width 58 mm | In distribution |
| 1 | Width 76 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 15 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 26 mm | In distribution |
| 1 | Width 114 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 31 mm | In distribution |
| 1 | Width 106 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 59 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 91 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 14 mm | In distribution |
| 1 | Width 85 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 69 mm | In distribution |
| 1 | Width 19 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 83 mm | In distribution |
| 1 | Width 96 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 20 mm | In distribution |
| 1 | Width 115 mm | In distribution |
| 1 | Width 29 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 101 mm | In distribution |
| 1 | Width 107 mm | In distribution |
| 1 | Width 70 mm | In distribution |
| 1 | Width 118 mm | In distribution |
| 1 | Width 117 mm | In distribution |
| 1 | Width 79 mm | In distribution |
| 1 | Width 81 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 30 mm | In distribution |
| 1 | Width 62 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 102 mm | In distribution |
| 1 | Width 63 mm | In distribution |
| 1 | Width 74 mm | In distribution |
| 1 | Width 17 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 73 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 61 mm | In distribution |
| 1 | Width 94 mm | In distribution |
| 1 | Width 23 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 28 mm | In distribution |
| 1 | Width 32 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 110 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 67 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 72 mm | In distribution |
| 1 | Width 16 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 80 mm | In distribution |
| 1 | Width 86 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 64 mm | In distribution |
| 1 | Width 108 mm | In distribution |
| 1 | Width 24 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 33 mm | In distribution |
| 1 | Width 90 mm | In distribution |
| 1 | Width 95 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 66 mm | In distribution |
| 1 | Width 60 mm | In distribution |
| 1 | Width 92 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 97 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 25 mm | In distribution |
| 1 | Width 99 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 71 mm | In distribution |
| 1 | Width 104 mm | In distribution |
| 1 | Width 84 mm | In distribution |
| 1 | Width 82 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 93 mm | In distribution |
| 1 | Width 68 mm | In distribution |
| 1 | Width 27 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 105 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 75 mm | In distribution |
| 1 | Width 88 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 77 mm | In distribution |
| 1 | Width 98 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 78 mm | In distribution |
| 1 | Width 112 mm | In distribution |
| 1 | Width 65 mm | In distribution |
| 1 | Width 116 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 111 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 22 mm | In distribution |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | In distribution | |
| 1 | Width 87 mm | In distribution |
| 1 | Width 100 mm | In distribution |
| 1 | Width 89 mm | In distribution |
| 1 | Width 18 mm | In distribution |
| 1 | Width 113 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 109 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.