Simpex Kirschner Wire
Smooth K-Wire, Single Diamond Tip; .045" DIA x 12" LG; Material: 316L Stainless Steel
12manufacturers in China registered for this device type
103catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Simpex Medical, Inc., United States |
|---|---|
| FDA product code | HTY |
| Device type | Pin, Fixation, Smooth |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K911505 |
| Record published | 2015-09-23 |
| Record revised | 2024-02-19 (version 4) |
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 |
| Sizes | Length 102 to 305 mm; outer diameter 0.7 to 1.6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KD-045-6S | Length 152 mm | In distribution |
| TK-062-9 | Outer Diameter 1.6 mm | In distribution |
| TK-045-4S | Outer Diameter 1.1 mm | In distribution |
| KD-045-12S | Length 305 mm | In distribution |
| KD-054-12 | Length 305 mm | In distribution |
| TK-062-4S | Outer Diameter 1.6 mm | In distribution |
| TK-062-4 | Length 102 mm | In distribution |
| TK-062-12 | Length 305 mm | In distribution |
| TK-045-9S | Length 229 mm | In distribution |
| KD-054-6 | Length 152 mm | In distribution |
| KD-062-4 | Outer Diameter 1.6 mm | In distribution |
| TK-062-6 | Length 152 mm | In distribution |
| TK-028-4 | Length 102 mm | In distribution |
| TK-054-4S | Length 102 mm | In distribution |
| KD-045-5S | Outer Diameter 1.1 mm | In distribution |
| KD-035-12 | Length 305 mm | In distribution |
| KD-028-4 | Outer Diameter 0.7 mm | In distribution |
| TK-054-12S | Length 305 mm | In distribution |
| TK-028-9S | Length 229 mm | In distribution |
| TK-035-12 | Outer Diameter 0.9 mm | In distribution |
| TK-028-12S | Outer Diameter 0.7 mm | In distribution |
| KD-054-9 | Outer Diameter 1.4 mm | In distribution |
| TK-054-5S | Outer Diameter 1.4 mm | In distribution |
| KD-028-5S | Outer Diameter 0.7 mm | In distribution |
| KD-035-12S | Outer Diameter 0.9 mm | In distribution |
| KD-062-5S | Outer Diameter 1.6 mm | In distribution |
| KD-028-12S | Length 305 mm | In distribution |
| KD-054-5 | Outer Diameter 1.4 mm | In distribution |
| KD-028-5 | Length 127 mm | In distribution |
| TK-054-5 | Length 127 mm | In distribution |
| TK-028-4S | Outer Diameter 0.7 mm | In distribution |
| TK-062-149S | Length 149 mm | In distribution |
| KD-035-5 | Outer Diameter 0.9 mm | In distribution |
| TK-035-9S | Outer Diameter 0.9 mm | In distribution |
| KD-045-4S | Length 102 mm | In distribution |
| TK-035-5S | Outer Diameter 0.9 mm | In distribution |
| TK-035-4S | Length 102 mm | In distribution |
| KD-054-4 | Length 102 mm | In distribution |
| KD-035-6 | Length 152 mm | In distribution |
| KD-062-12 | Outer Diameter 1.6 mm | In distribution |
| KD-045-5 | Length 127 mm | In distribution |
| KD-035-4S | Outer Diameter 0.9 mm | In distribution |
| TK-062-9S | Length 229 mm | In distribution |
| KD-035-9S | Length 229 mm | In distribution |
| KD-028-6 | Outer Diameter 0.7 mm | In distribution |
| KD-054-6S | Outer Diameter 1.4 mm | In distribution |
| TK-062-5 | Outer Diameter 1.6 mm | In distribution |
| KD-045-6 | Outer Diameter 1.1 mm | In distribution |
| KD-054-4S | Outer Diameter 1.4 mm | In distribution |
| TK-054-12 | Outer Diameter 1.4 mm | In distribution |
| KD-062-9 | Length 229 mm | In distribution |
| KD-054-5S | Length 127 mm | In distribution |
| KD-028-9S | Outer Diameter 0.7 mm | In distribution |
| TK-028-5 | Outer Diameter 0.7 mm | In distribution |
| KD-035-9 | Outer Diameter 0.9 mm | In distribution |
| TK-028-9 | Outer Diameter 0.7 mm | In distribution |
| KD-035-6S | Outer Diameter 0.9 mm | In distribution |
| TK-028-6S | Outer Diameter 0.7 mm | In distribution |
| TK-054-9S | Outer Diameter 1.4 mm | In distribution |
| TK-035-12S | Length 305 mm | In distribution |
| TK-045-12S | Outer Diameter 1.1 mm | In distribution |
| TK-035-4 | Outer Diameter 0.9 mm | In distribution |
| KD-028-9 | Length 229 mm | In distribution |
| KD-045-9 | Length 229 mm | In distribution |
| TK-054-6 | Outer Diameter 1.4 mm | In distribution |
| KD-054-9S | Length 229 mm | In distribution |
| KD-028-12 | Outer Diameter 0.7 mm | In distribution |
| TK-035-6S | Length 152 mm | In distribution |
| TK-054-6S | Length 152 mm | In distribution |
| TK-045-6 | Length 152 mm | In distribution |
| TK-028-6 | Length 152 mm | In distribution |
| TK-045-12 | Length 305 mm | In distribution |
| TK-045-4 | Length 102 mm | In distribution |
| TK-035-6 | Outer Diameter 0.9 mm | In distribution |
| KD-028-4S | Length 102 mm | In distribution |
| TK-035-149S | Outer Diameter 0.9 mm | In distribution |
| KD-054-12S | Outer Diameter 1.4 mm | In distribution |
| KD-045-9S | Outer Diameter 1.1 mm | In distribution |
| TK-062-5S | Length 127 mm | In distribution |
| TK-035-9 | Length 229 mm | In distribution |
| TK-045-5S | Length 127 mm | In distribution |
| KD-045-12 | Outer Diameter 1.1 mm | In distribution |
| TK-035-5 | Length 127 mm | In distribution |
| TK-062-12S | Outer Diameter 1.6 mm | In distribution |
| KD-035-4 | Length 102 mm | In distribution |
| TK-045-6S | Outer Diameter 1.1 mm | In distribution |
| TK-028-5S | Length 127 mm | In distribution |
| KD-062-4S | Length 102 mm | In distribution |
| TK-045-149S | Outer Diameter 1.1 mm | In distribution |
| KD-035-5S | Length 127 mm | In distribution |
| KD-045-4 | Outer Diameter 1.1 mm | In distribution |
| KD-062-12S | Length 305 mm | In distribution |
| TK-045-5 | Outer Diameter 1.1 mm | In distribution |
| KD-062-5 | Length 127 mm | In distribution |
| KD-062-6S | Length 152 mm | In distribution |
| TK-028-12 | Length 305 mm | In distribution |
| TK-045-9 | Outer Diameter 1.1 mm | In distribution |
| TK-054-9 | Length 229 mm | In distribution |
| TK-054-4 | Outer Diameter 1.4 mm | In distribution |
| KD-028-6S | Length 152 mm | In distribution |
| KD-062-9S | Outer Diameter 1.6 mm | In distribution |
| TK-062-6S | Outer Diameter 1.6 mm | In distribution |
| KD-062-6 | Outer Diameter 1.6 mm | 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 |
|---|---|
| K911452 | 1991-04-12 |
| K911505 | 1991-04-12 |
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.