Pediatric Nailing Platform Femur
Pediatric Nailing Platform Femur is an intramedullary fixation system for children and adults of small stature. Its stainless-steel nail is placed in the femoral canal to align and…
Pediatric Nailing Platform Femur is an intramedullary fixation system for children and adults of small stature. Its stainless-steel nail is placed in the femoral canal to align and stabilize bone fragments.
Holes at the nail ends accept transverse stainless-steel locking screws for added stabilization. An end cap closes the head of the nail to limit bone ingrowth and facilitate later removal.
Listed Item
5.0mm x 87.5mm Fully Threaded Interlocking Screw, 4.3mm Core
Child and Adolescent Nails
Separate child and adolescent nail ranges provide different diameters and lengths. The implants are 316L stainless steel, supplied nonsterile for single use. Associated instruments may be single-use or reusable; both implants and instruments require sterilization by the user.
17manufacturers in China registered for this device type
249catalogue numbers in this listing
6510(k) clearances naming this product code
31recalls on this code
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 | Orthopediatrics, Corp, United States |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K220679 |
| Record published | 2022-09-16 |
| Record revised | 2026-06-23 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2026-06-15 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-1506-4086 | In distribution | |
| 00-1506-6052 | In distribution | |
| 00-1506-2095 | In distribution | |
| 00-1506-5105 | In distribution | |
| 00-1506-3116 | In distribution | |
| 00-1506-6015 | In distribution | |
| 00-1506-5115 | In distribution | |
| 00-1506-4098 | In distribution | |
| 00-1506-2096 | In distribution | |
| 00-1503-1250 | In distribution | |
| 00-1506-5116 | In distribution | |
| 00-1504-1148 | In distribution | |
| 00-1506-6035 | In distribution | |
| 00-1501-3005 | In distribution | |
| 00-1506-5107 | In distribution | |
| 00-1506-4096 | In distribution | |
| 00-1506-6030 | In distribution | |
| 00-1506-4088 | In distribution | |
| 00-1506-2090 | In distribution | |
| 00-1506-2098 | In distribution | |
| 00-1506-4087 | In distribution | |
| 00-1506-4092 | In distribution | |
| 00-1506-3120 | In distribution | |
| 00-1506-3108 | In distribution | |
| 00-1504-1246 | In distribution | |
| 00-1503-0948 | In distribution | |
| 00-1506-4097 | In distribution | |
| 00-1506-3107 | In distribution | |
| 00-1503-1244 | In distribution | |
| 00-1503-3020 | In distribution | |
| 00-1506-5114 | In distribution | |
| 00-1506-4095 | In distribution | |
| 00-1506-6045 | In distribution | |
| 00-1504-1244 | In distribution | |
| 00-1506-2094 | In distribution | |
| 00-1504-1150 | In distribution | |
| 00-1504-1046 | In distribution | |
| 00-1506-4093 | In distribution | |
| 00-1504-1248 | In distribution | |
| 00-1506-3115 | In distribution | |
| 00-1503-0946 | In distribution | |
| 00-1506-6016 | In distribution | |
| 00-1506-5104 | In distribution | |
| 00-1506-6018 | In distribution | |
| 00-1506-6034 | In distribution | |
| 00-1506-3117 | In distribution | |
| 00-1503-1048 | In distribution | |
| 00-1506-6028 | In distribution | |
| 00-1506-6046 | In distribution | |
| 00-1506-5113 | In distribution | |
| 00-1503-3000 | In distribution | |
| 00-1506-6044 | In distribution | |
| 00-1506-6053 | In distribution | |
| 00-1506-6033 | In distribution | |
| 00-1506-6050 | In distribution | |
| 00-1504-0944 | In distribution | |
| 00-1503-3005 | In distribution | |
| 00-1506-3118 | In distribution | |
| 00-1504-1146 | In distribution | |
| 00-1506-3102 | In distribution | |
| 00-1504-1050 | In distribution | |
| 00-1503-3010 | In distribution | |
| 00-1506-2100 | In distribution | |
| 00-1506-6057 | In distribution | |
| 00-1501-3015 | In distribution | |
| 00-1506-5108 | In distribution | |
| 00-1504-0946 | In distribution | |
| 00-1506-4100 | In distribution | |
| 00-1503-1150 | In distribution | |
| 00-1504-0950 | In distribution | |
| 00-1503-1144 | In distribution | |
| 00-1506-6038 | In distribution | |
| 00-1503-1148 | In distribution | |
| 00-1503-1248 | In distribution | |
| 00-1506-6047 | In distribution | |
| 00-1501-3020 | In distribution | |
| 00-1506-6026 | In distribution | |
| 00-1506-4094 | In distribution | |
| 00-1506-6036 | In distribution | |
| 00-1506-2097 | In distribution | |
| 00-1506-6055 | In distribution | |
| 00-1506-6060 | In distribution | |
| 00-1506-5110 | In distribution | |
| 00-1506-3105 | In distribution | |
| 00-1503-1146 | In distribution | |
| 00-1506-2092 | In distribution | |
| 00-1504-0948 | In distribution | |
| 00-1506-3114 | In distribution | |
| 00-1506-6054 | In distribution | |
| 00-1506-3112 | In distribution | |
| 00-1506-5112 | In distribution | |
| 00-1503-0944 | In distribution | |
| 00-1503-3015 | In distribution | |
| 00-1503-0950 | In distribution | |
| 00-1506-3103 | In distribution | |
| 00-1506-3104 | In distribution | |
| 00-1504-1144 | In distribution | |
| 00-1504-1048 | In distribution | |
| 00-1506-5102 | In distribution | |
| 00-1506-2093 | In distribution | |
| 00-1506-2088 | In distribution | |
| 00-1503-1044 | In distribution | |
| 00-1506-6042 | In distribution | |
| 00-1506-4090 | In distribution | |
| 00-1503-1050 | In distribution | |
| 00-1506-6043 | In distribution | |
| 00-1506-5117 | In distribution | |
| 00-1506-6023 | In distribution | |
| 00-1506-3113 | In distribution | |
| 00-1506-3106 | In distribution | |
| 00-1506-6025 | In distribution | |
| 00-1506-6032 | In distribution | |
| 00-1506-6040 | In distribution | |
| 00-1506-2087 | In distribution | |
| 00-1501-3010 | In distribution | |
| 00-1506-6020 | In distribution | |
| 00-1506-6024 | In distribution | |
| 00-1506-5120 | In distribution | |
| 00-1506-5103 | In distribution | |
| 00-1501-3000 | In distribution | |
| 00-1504-1044 | In distribution | |
| 00-1506-6037 | In distribution | |
| 00-1506-3110 | In distribution | |
| 00-1506-6027 | In distribution | |
| 00-1504-1250 | In distribution | |
| 00-1506-6058 | In distribution | |
| 00-1506-6017 | In distribution | |
| 00-1506-5118 | In distribution | |
| 00-1506-2086 | In distribution | |
| 00-1506-6022 | In distribution | |
| 00-1506-6048 | In distribution | |
| 00-1503-1046 | In distribution | |
| 00-1506-6056 | In distribution | |
| 00-1506-5106 | In distribution | |
| 00-1503-1246 | In distribution | |
| 10-1501-0928 | Withdrawn | |
| 10-1501-0730 | Withdrawn | |
| 10-1502-0938 | Withdrawn | |
| 10-1502-0842 | Withdrawn | |
| 10-1503-0940 | Withdrawn | |
| 10-1501-0834 | Withdrawn | |
| 10-1503-1038 | Withdrawn | |
| 10-1503-1140 | Withdrawn | |
| 10-1502-0940 | Withdrawn | |
| 10-1502-0728 | Withdrawn | |
| 10-1501-0738 | Withdrawn | |
| 10-1504-1230 | Withdrawn | |
| 10-1503-1234 | Withdrawn | |
| 10-1502-0828 | Withdrawn | |
| 10-1501-0732 | Withdrawn | |
| 10-1502-0834 | Withdrawn | |
| 10-1504-0932 | Withdrawn | |
| 10-1504-1132 | Withdrawn | |
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| 10-1503-1142 | Withdrawn | |
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| 10-1503-1030 | Withdrawn | |
| 10-1504-1136 | Withdrawn | |
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| 10-1502-0928 | Withdrawn | |
| 10-1503-1132 | Withdrawn | |
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| 10-1502-0724 | Withdrawn | |
| 10-1504-1236 | Withdrawn | |
| 10-1502-0824 | Withdrawn | |
| 10-1503-1134 | Withdrawn | |
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| 10-1501-0724 | Withdrawn | |
| 10-1501-0826 | Withdrawn | |
| 10-1503-1130 | Withdrawn | |
| 10-1504-1232 | Withdrawn | |
| 10-1501-0838 | Withdrawn | |
| 10-1503-1138 | Withdrawn | |
| 10-1504-1034 | Withdrawn | |
| 10-1504-1038 | Withdrawn | |
| 10-1504-1242 | Withdrawn | |
| 10-1501-0736 | Withdrawn | |
| 10-1502-0836 | Withdrawn | |
| 10-1502-0738 | Withdrawn | |
| 10-1501-0824 | Withdrawn | |
| 10-1504-1240 | Withdrawn | |
| 10-1502-0730 | Withdrawn | |
| 10-1503-1232 | Withdrawn | |
| 10-1503-0930 | Withdrawn | |
| 10-1501-0830 | Withdrawn | |
| 10-1501-0934 | Withdrawn | |
| 10-1502-0934 | Withdrawn | |
| 10-1504-1036 | Withdrawn | |
| 10-1502-0720 | Withdrawn | |
| 10-1504-0938 | Withdrawn | |
| 10-1504-0930 | Withdrawn | |
| 10-1504-0934 | Withdrawn | |
| 10-1503-0934 | Withdrawn | |
| 10-1501-0930 | Withdrawn | |
| 10-1502-0736 | Withdrawn | |
| 10-1504-1234 | Withdrawn | |
| 10-1504-1134 | Withdrawn | |
| 10-1503-0932 | Withdrawn | |
| 10-1501-0936 | Withdrawn | |
| 10-1501-0722 | Withdrawn | |
| 10-1503-1034 | Withdrawn | |
| 10-1503-1040 | Withdrawn | |
| 10-1504-1042 | Withdrawn | |
| 10-1504-1238 | Withdrawn | |
| 10-1502-0830 | Withdrawn | |
| 10-1502-0732 | Withdrawn | |
| 10-1504-1142 | Withdrawn | |
| 10-1503-1242 | Withdrawn | |
| 10-1503-1238 | Withdrawn | |
| 10-1501-0734 | Withdrawn | |
| 10-1504-0928 | Withdrawn | |
| 10-1503-0942 | Withdrawn | |
| 10-1503-1032 | Withdrawn | |
| 10-1501-0840 | Withdrawn | |
| 10-1504-1032 | Withdrawn | |
| 10-1504-1040 | Withdrawn | |
| 10-1501-0720 | Withdrawn | |
| 10-1502-0734 | Withdrawn | |
| 10-1504-1140 | Withdrawn | |
| 10-1501-0728 | Withdrawn | |
| 10-1504-0942 | Withdrawn | |
| 10-1504-0940 | Withdrawn | |
| 10-1503-1240 | Withdrawn | |
| 10-1502-0826 | Withdrawn | |
| 10-1502-0930 | Withdrawn | |
| 10-1501-0726 | Withdrawn | |
| 10-1502-0722 | Withdrawn | |
| 10-1503-1036 | Withdrawn | |
| 10-1503-1236 | Withdrawn | |
| 10-1501-0828 | Withdrawn | |
| 10-1502-0936 | Withdrawn | |
| 10-1504-1130 | Withdrawn | |
| 10-1502-0840 | Withdrawn | |
| 10-1501-0942 | Withdrawn | |
| 10-1501-0836 | Withdrawn | |
| 10-1501-0842 | Withdrawn | |
| 10-1501-0832 | Withdrawn | |
| 10-1503-0928 | Withdrawn | |
| 10-1503-0936 | Withdrawn | |
| 10-1501-0932 | Withdrawn | |
| 10-1502-0832 | Withdrawn | |
| 10-1503-0938 | Withdrawn | |
| 10-1502-0726 | Withdrawn | |
| 10-1501-0940 | 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 |
|---|---|
| K250623 | 2025-04-01 |
| K231266 | 2023-08-21 |
| K220679 | 2022-07-20 |
| K190321 | 2019-10-09 |
| K172583 | 2018-05-10 |
| K083726 | 2009-03-11 |
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-08-19 | Class II | Nonconforming Material/Component | Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures. | 969 total | 2020-04-30 |
| 2019-08-19 | Class II | Nonconforming Material/Component | Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures. | 969 total | 2020-04-30 |
| 2019-08-19 | Class II | Device Design | Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures | 211 units | 2020-10-26 |
| 2016-11-18 | Class III | Labeling mix-ups | Labeled as a 48mm Cortical Screw but measuring at 50mm | 22 units | 2017-07-27 |
| 2012-09-13 | Class II | Reprocessing Controls | A complaint received from sales representative that a replenishment instrument was too short. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended. | 78 | 2013-09-18 |
| 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
| 2009-07-21 | Not classified | Device Design | The potential exists for the nails to fracture during insertion of the nail. | 23 of all products | 2010-10-25 |
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.