Pin, Fixation, Threaded
The threaded K-wire is used for bone fracture fixation, joint fusion or bone reconstruction. It may also serve as a guide pin when inserting other osteosynthesis implants. The listed wire…
The threaded K-wire is used for bone fracture fixation, joint fusion or bone reconstruction. It may also serve as a guide pin when inserting other osteosynthesis implants. The listed wire has a threaded shaft and a trocar point.
The aap wire range offers different diameters and lengths for the required bone procedure. Threaded trocar-point K-wires span diameters from 0.8 to 3.0 mm and lengths from 45 to 380 mm, covering the listed 2.0 mm by 150 mm configuration.
Listed Item
K-wire with thread and trocar point, ø2.0, L 150
Preparation and Removal
The devices are supplied nonsterile and require sterilization before use. When used as fixation implants, they are removed after fracture healing. The range includes titanium alloy and implant stainless steel options.
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (2). 4 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| 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 |
| Aike (Shanghai) Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 4 |
Record
| Listed by | AAP Implantate AG, Germany |
|---|---|
| FDA product code | JDW |
| Device type | Pin, Fixation, Threaded |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Manufacturer |
| 510(k) | K131459 |
| Record published | 2016-08-18 |
| Record revised | 2025-07-14 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2025-01-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| NK 1030-27-2 | 10 | In distribution | |
| NK 1016-15-2 | 10 | In distribution | |
| NK 1030-27 | 10 | In distribution | |
| NK 1030-22 | 10 | In distribution | |
| NK 1012-20 | 10 | In distribution | |
| NK 1025-27 | 10 | In distribution | |
| NK 1018-20 | 10 | In distribution | |
| NK 1012-20-2 | 10 | In distribution | |
| NK 1016-20 | 10 | In distribution | |
| NK 1016-20-2 | 10 | In distribution | |
| NK 1010-15 | 10 | In distribution | |
| NK 1012-15-2 | 10 | In distribution | |
| NK 1020-27 | 10 | In distribution | |
| NK 1016-15 | 10 | In distribution | |
| NK 1018-15 | 10 | In distribution | |
| NK 1030-22-2 | 10 | In distribution | |
| NK 1020-25 | 10 | In distribution | |
| NK 1014-15 | 10 | In distribution | |
| NK 1012-15 | 10 | In distribution | |
| NK 1020-15 | 10 | Withdrawn | |
| NK 1020-20 | 10 | Withdrawn | |
| NK 1025-15 | 10 | Withdrawn | |
| NK 1015-45 | 4 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Orthofix Modulsystem | Orthofix SRL | 583 |
| Jet-X | Smith & Nephew, Inc. | 234 |
| Apex | Stryker GmbH | 176 |
| Ilizarov | Smith & Nephew, Inc. | 149 |
| Orthex Half Pin | Orthopediatrics, Corp | 131 |
| Pin, Fixation, Threaded | Smith & Nephew, Inc. | 127 |
| Spatial Frame | Smith & Nephew, Inc. | 127 |
| PIN Screw | BK Meditech Co., Ltd. | 118 |
| Ilizarov Systems | Medicalplastic | 115 |
| Dynamic Axial Fixator | Orthofix SRL | 96 |
| Hoffmann LRF | Stryker GmbH | 82 |
| Other External Fixation | Smith & Nephew, Inc. | 78 |
Showing 12 of 378. All products under Pin, Fixation, Threaded
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K131459 | 2013-10-17 |
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.