Smartpin
Smartpin Self-Reinforced Technology, Ø 1.5 X 20 MM
12manufacturers in China registered for this device type
54catalogue 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 | ConMed Corporation, United States |
|---|---|
| FDA product code | HTY |
| Device type | Pin, Fixation, Smooth |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-10-24 |
| Record revised | 2026-06-22 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 40 °C; Special storage condition: KEEP DRY; Storage environment temperature up to 104 °F |
| Sizes | Length 10 to 70 mm; outer diameter 1.1 to 4.5 mm |
| Distribution end date | 2022-06-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 122060 | Outer Diameter 2 mm | In distribution |
| 121510 | Outer Diameter 1.5 mm | In distribution |
| 121560 | Length 60 mm | In distribution |
| 121550 | Outer Diameter 1.5 mm | In distribution |
| 122070 | Length 70 mm | In distribution |
| 121570 | Length 70 mm | In distribution |
| 121540 | Diameter 1.5 x 40 mm | In distribution |
| 122025 | Outer Diameter 2 mm | In distribution |
| 121520 | Length 20 mm | In distribution |
| 122030 | Length 30 mm | In distribution |
| 122040 | Outer Diameter 2 mm | In distribution |
| 122050 | Outer Diameter 2 mm | In distribution |
| 122020 | Length 20 mm | In distribution |
| 121530 | Length 30 mm | In distribution |
| 122040 | Length 40 mm | Withdrawn |
| 122050 | Outer Diameter 2 mm | Withdrawn |
| 121140 | Length 40 mm | Withdrawn |
| 121130 | Length 30 mm | Withdrawn |
| 124570 | Length 70 mm | Withdrawn |
| 123240 | Length 40 mm | Withdrawn |
| 121120 | Length 20 mm | Withdrawn |
| 123250 | Length 50 mm | Withdrawn |
| 124560 | Outer Diameter 4.5 mm | Withdrawn |
| 121540 | Outer Diameter 1.5 mm | Withdrawn |
| 123250 | Outer Diameter 3.2 mm | Withdrawn |
| 124550 | Length 50 mm | Withdrawn |
| 122035 | Length 35 mm | Withdrawn |
| 123230 | Outer Diameter 3.2 mm | Withdrawn |
| 122030 | Length 30 mm | Withdrawn |
| 121510 | Outer Diameter 1.5 mm | Withdrawn |
| 121140 | Length 40 mm | Withdrawn |
| 122060 | Outer Diameter 2 mm | Withdrawn |
| 123260 | Length 60 mm | Withdrawn |
| 123270 | Outer Diameter 3.2 mm | Withdrawn |
| 124540 | Length 40 mm | Withdrawn |
| 124540 | Length 40 mm | Withdrawn |
| 121130 | Length 30 mm | Withdrawn |
| 121120 | Outer Diameter 1.1 mm | Withdrawn |
| 123260 | Length 60 mm | Withdrawn |
| 121550 | Length 50 mm | Withdrawn |
| 121520 | Outer Diameter 1.5 mm | Withdrawn |
| 124550 | Length 50 mm | Withdrawn |
| 124570 | Outer Diameter 4.5 mm | Withdrawn |
| 124560 | Outer Diameter 4.5 mm | Withdrawn |
| 121570 | Length 70 mm | Withdrawn |
| 122035 | Outer Diameter 2 mm | Withdrawn |
| 122025 | Length 25 mm | Withdrawn |
| 121560 | Length 60 mm | Withdrawn |
| 121530 | Length 30 mm | Withdrawn |
| 122020 | Length 20 mm | Withdrawn |
| 123270 | Outer Diameter 3.2 mm | Withdrawn |
| 122070 | Outer Diameter 2 mm | Withdrawn |
| 123230 | Outer Diameter 3.2 mm | Withdrawn |
| 123240 | Outer Diameter 3.2 mm | 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.