Extremity Medical, LLC · Class II · Cleared Oct 8, 2025
| K-number | K250536 |
| Device name | MetaFore Small Screw System |
| Applicant | Extremity Medical, LLC |
| Product code | HWC |
| Device class | Class II |
| Decision date | Oct 8, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The MetaFore Small Screw System is a set of implantable titanium alloy screws and accessories used for fixation of bone fractures and reconstruction in hand and forefoot surgery. The system includes 2.0mm solid snap-off screws, 2.5mm and 3.0mm cannulated headless screws, and 3.0mm and 4.0mm cannulated beveled screws in various lengths, along with surgical instruments for implantation.
The device uses titanium alloy (Ti-6Al-4V ELI per ASTM F136) for all implantable screws, identical to the predicate devices. The screws function as temporary fixation devices for bone repair and reconstruction. Both the subject and predicate devices share the same material composition, design principles, and mechanism of action for bone fixation.
Torsional strength and driving torque testing per ASTM F543; engineering analysis of axial pullout strength per Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway.
The MetaFore Small Screw System is substantially equivalent to its predicates (K153182 and K150772) based on identical material composition (Ti-6Al-4V ELI), equivalent mechanical properties demonstrated through ASTM testing, matching indications for use in hand and forefoot surgery, and identical principles of operation as temporary bone fixation devices. No new technological risks were identified through non-clinical testing.
View the full FDA submission: accessdata.fda.gov