Pediflex
The FDA filing identifies PediFlex as a flexible nail system. It includes stainless-steel and titanium flexible nails, interlocking clamps, clamp screws and end caps. It is intended to fix…
The FDA filing identifies PediFlex as a flexible nail system. It includes stainless-steel and titanium flexible nails, interlocking clamps, clamp screws and end caps.
It is intended to fix diaphyseal fractures of long bones when the medullary canal is narrow or implant flexibility is required. Stated populations include all patients for upper-extremity fractures and pediatric or small-stature patients for lower-extremity fractures.
Listed Item
Ti Flex Nail End Cap, 3.5mm
Nail Accessories
Interlocking clamps are optional and hold flexible nails in place after insertion by clamping the nail and being fixed to bone. End caps are optional and are not a structural element or a source of additional strength to the construct.
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Aplus (Guangzhou) Medical Technology Company | Guangzhou | Guangdong | Contract manufacturer | 6 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Orthopediatrics, Corp, United States |
|---|---|
| FDA product code | HTY |
| Device type | Pin, Fixation, Smooth |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K251362 |
| Record published | 2025-12-11 |
| Record revised | 2025-02-06 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-1001-1135 | In distribution | |
| 00-1001-1020 | In distribution | |
| 01-1001-0600 | In distribution | |
| 00-1000-420 | In distribution | |
| 00-1001-1140 | In distribution | |
| 00-1001-1040 | In distribution | |
| 00-1001-1145 | In distribution | |
| 00-1000-430 | In distribution | |
| 00-1001-1115 | In distribution | |
| 00-1001-1130 | In distribution | |
| 00-1000-415 | In distribution | |
| 00-1000-425 | In distribution | |
| 00-1001-1125 | In distribution | |
| 00-1001-1030 | In distribution | |
| 00-1001-1120 | In distribution | |
| 00-1001-1025 | In distribution | |
| 00-1000-440 | In distribution | |
| 00-1000-435 | In distribution | |
| 00-1001-1035 | In distribution | |
| 00-1001-1015 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rondo’ | Citieffe SRL | 265 |
| HNM Medical | HNM Stainless, LLC. | 232 |
| Kmedic | Teleflex Medical LLC | 227 |
| gSource | Gsource, LLC. | 221 |
| MicroAire® | Microaire Surgical Instruments LLC | 213 |
| Orthomed | Ortho-MED, Inc. | 163 |
| mahe medical GmbH | Mahe Intl., Inc. | 160 |
| Pin, Fixation, Smooth | Key Surgical, LLC | 134 |
| Pin, Fixation, Smooth | Stryker GmbH | 134 |
| Aptus | Medartis Inc. | 134 |
| Key Surgical K-Wires and Steinmann Pins | Key Surgical, LLC | 126 |
| PedFlex Flexible Nailing System | Orthopediatrics, Corp | 119 |
Showing 12 of 682. All products under Pin, Fixation, Smooth
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251362 | 2025-06-24 |
| K201838 | 2021-01-29 |
| K082375 | 2008-10-17 |
| K081097 | 2008-06-03 |
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.