Hyperflex Medical · Class II · Cleared Dec 11, 2025
| K-number | K252997 |
| Device name | HyperFlex® Bunion Correction System |
| Applicant | Hyperflex Medical |
| Product code | HRS |
| Device class | Class II |
| Decision date | Dec 11, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3030 |
The HyperFlex® Bunion Correction System is an implantable device used to correct hallux valgus deformity (bunions) in adults and pediatric patients aged ≥13 years with fused growth plates. It consists of components that attach to the 1st and 2nd metatarsals joined by a flexible central section, holding the intermetatarsal angle between these bones without restricting range of motion.
The subject device differs from the primary predicate (K241995) in that its metatarsal components are manufactured from titanium alloy rather than stainless steel. Packaging and sterilization methods have also been changed. The device is offered in multiple sizes to accommodate varying patient anatomy.
Static and fatigue tensile testing; screw torsional strength testing per ASTM F543-17; screw insertion torque testing per ASTM F543-17; screw pullout strength testing per ASTM F543-17; particulate testing per ASTM 1877-16; and additive manufacturing characterization.
The subject device is substantially equivalent to its predicates because it has the same intended use, similar design principles, comparable technological characteristics, and similar materials and sterilization methods. Non-clinical testing demonstrated the device can withstand physiological loading and performs as well as or better than the predicate devices.
View the full FDA submission: accessdata.fda.gov