K-Wire
The NEWDEAL K-WIRE is available in four different designs, with one or two sharp self-drilling tips either smooth or partially threaded. One part is fixed on a standard surgical power tool…
The NEWDEAL K-WIRE is available in four different designs, with one or two sharp self-drilling tips either smooth or partially threaded. One part is fixed on a standard surgical power tool equipment for insertion. They are made out of stainless steel and are dedicated to fixation of bone fractures, bone reconstruction, as guide pins for insertion of other implants.
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 | Newdeal Sas, United States |
|---|---|
| FDA product code | HTY |
| Device type | Pin, Fixation, Smooth |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| 510(k) | K022599 |
| Record published | 2018-10-16 |
| Record revised | 2026-06-30 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Storage | Special storage condition: Do not use if package is damaged |
| Distribution end date | 2027-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 115516ND | In distribution | |
| 115101ND | 1.0mm diam. x 100mm length | In distribution |
| 115225ND | 2.5mm diam. x 200mm length | In distribution |
| 115116ND | 1.6mm diam. x 150mm length | In distribution |
| 115100ND | 1.0mm diam. x 100mm length | In distribution |
| 115070ND | 1.0mm diam. x 70mm length | In distribution |
| 115216ND | 1.6mm diam. x 150mm length | In distribution |
| 115071ND | 1.0mm diam. x 70mm length | Withdrawn |
| 115171ND | 1.0mm diam. x 70mm length | Withdrawn |
| 115425ND | Withdrawn | |
| 115316ND | 1.6mm diam. x 150mm length | Withdrawn |
| 115111ND | 1.0mm diam. x 100mm length | Withdrawn |
| 115110ND | 1.0mm diam. x 100mm length | Withdrawn |
| 115416ND | 1.6mm diam. x 150mm length | Withdrawn |
| 115170ND | 1.0mm diam. x 70mm length | Withdrawn |
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 |
|---|---|
| K103623 | 2012-03-20 |
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.