Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of findgers and toes. Pre-sterilized, all inclusive implant procedure…
Product received FDA 510(k) clearance for: small bone fixation, reconstruction and fusion such as inter-digital fusion of findgers and toes. Pre-sterilized, all inclusive implant procedure tray contains: 1ea Instrument containing a Nitinol Intramedullary Fixation Scaffold (SuperScaffold™) implant held in place by use of a locking pin; 1ea 1.1mm (0.045″) double trocar K-wire with sharps protection, and 1ea 2.2mm Drill Bit with integral handle for manual use.
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.
Record
Regulatory record for SuperScaffold™ | Listed by | Metric Medical Devices, 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 |
| Record published | 2018-04-25 |
| Record revised | 2025-07-14 (version 3) |
Specifications
Specifications | MRI safety | MR Conditional |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Not subjected to storage or shipping temperatures in excess of 76.7°C (170°F) |
| Sizes | Length 6.5 mm; outer diameter 2.2 mm |
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.