Pin, Fixation, Smooth
K-wire with trocar point and thread, ø1.6, L 150
12manufacturers in China registered for this device type
82catalogue numbers in this listing
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 | AAP Implantate AG, Germany |
|---|---|
| FDA product code | HTY |
| Device type | Pin, Fixation, Smooth |
| 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 7) |
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 0010-31 | 10 | In distribution | |
| NK 0025-25 | 10 | In distribution | |
| NK 0012-28 | 10 | In distribution | |
| NK 0030-08 | 10 | In distribution | |
| NK 0016-20 | 10 | In distribution | |
| NK 0016-28 | 10 | In distribution | |
| NK 0012-25 | 10 | In distribution | |
| NK 0020-15 | 10 | In distribution | |
| NK 0012-10 | 10 | In distribution | |
| NK 0016-18 | 10 | In distribution | |
| NK 0018-25-2 | 10 | In distribution | |
| NK 0010-15-2 | 10 | In distribution | |
| NK 0025-31 | 10 | In distribution | |
| NK 2016-15 | 10 | In distribution | |
| NK 0012-15-2 | 10 | In distribution | |
| NK 0008-10 | 10 | In distribution | |
| NK 2014-15 | 10 | In distribution | |
| NK 0016-25-2 | 10 | In distribution | |
| NK 0020-20 | 10 | In distribution | |
| NK 0014-25 | 10 | In distribution | |
| NK 0020-25 | 10 | In distribution | |
| NK 0018-15-2 | 10 | In distribution | |
| NK 0015-15 | 10 | In distribution | |
| NK 0025-28 | 10 | In distribution | |
| NK 0018-31 | 10 | In distribution | |
| NK 0010-20 | 10 | In distribution | |
| NK 0030-15 | 10 | In distribution | |
| NK 0012-15 | 10 | In distribution | |
| NK 0014-15 | 10 | In distribution | |
| NK 2010-15 | 10 | In distribution | |
| NK 0016-15-2 | 10 | In distribution | |
| NK 0015-31 | 10 | In distribution | |
| NK 0018-20 | 10 | In distribution | |
| NK 0020-15-2 | 10 | In distribution | |
| NK 0012-20 | 10 | In distribution | |
| NK 0014-20 | 10 | In distribution | |
| NK 0020-31 | 10 | In distribution | |
| NK 0020-25-2 | 10 | In distribution | |
| NK 0025-15-2 | 10 | In distribution | |
| NK 0020-28 | 10 | In distribution | |
| NK 0010-15 | 10 | In distribution | |
| GDW-2060-0001 | In distribution | ||
| NK 2012-15 | 10 | In distribution | |
| NK 0018-25 | 10 | In distribution | |
| NK 0008-15 | 10 | In distribution | |
| NK 0016-25 | 10 | In distribution | |
| NK 0012-31 | 10 | In distribution | |
| NK 1024-25 | In distribution | ||
| NK 0014-31 | 10 | In distribution | |
| NK 0014-25-2 | 10 | In distribution | |
| NK 0014-08 | 10 | In distribution | |
| NK 0018-15 | 10 | In distribution | |
| NK 0016-15 | 10 | In distribution | |
| NK 0010-28 | 10 | In distribution | |
| NK 0025-20 | 10 | In distribution | |
| NK 2016-15-2 | 10 | In distribution | |
| NK 2012-15-2 | 10 | In distribution | |
| NK 0014-15-2 | 10 | In distribution | |
| NK 0025-15 | 10 | In distribution | |
| NK 0016-31 | 10 | In distribution | |
| NK 2014-15-2 | 10 | In distribution | |
| NK 0010-25 | 10 | In distribution | |
| NK 0014-28 | 10 | In distribution | |
| NK 2008-15 | 10 | In distribution | |
| NK 0018-31-2 | 10 | Withdrawn | |
| NK 0024-43 | Withdrawn | ||
| NK 0010-10 | 10 | Withdrawn | |
| 430470SINGLE | Withdrawn | ||
| NK 0008-31 | 10 | Withdrawn | |
| NK 0030-25 | 10 | Withdrawn | |
| NK 0012-25-2 | 10 | Withdrawn | |
| 430480SINGLE | Withdrawn | ||
| 430125SINGLE | Withdrawn | ||
| NK 0017-20 | 10 | Withdrawn | |
| 430165SINGLE | Withdrawn | ||
| NK 2020-15 | 10 | Withdrawn | |
| NG 8308-28 | Withdrawn | ||
| NK 2025-31 | 10 | Withdrawn | |
| NK 0020-31-2 | 10 | Withdrawn | |
| NK 0017-31 | 10 | Withdrawn | |
| NK 0030-10 | 10 | Withdrawn | |
| NK 0030-06 | 10 | 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
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.