Medline UNITE® REFLEX® Hybrid Nitinol Implant System

The Medline UNITE® REFLEX® Hybrid Nitinol Implant System is a bone fixation device made from nickel-titanium alloy used to treat fractures, fusions, and osteotomies of foot and ankle bones. It includes implants in various sizes with polyaxial locking holes and compression slots that accept 2.7mm, 3.5mm, and 4.0mm cortical screws, along with reusable and disposable instrumentation for implantation. Implants are intended for single use only and must be steam sterilized at the healthcare facility before use.

The device is manufactured from nitinol (nickel-titanium alloy per ASTM F2063) with chemical etching and passivation to form a protective oxidation layer. It offers identical leg lengths of 16mm, 18mm, and 20mm to the predicate, plus an additional 22mm option. Bridge widths differ from the predicate (7.3mm and 10mm versus 1.5mm, 4mm, and 5mm), and the new device includes polyaxial locking holes and compression slots not present in the predicate. Both devices use straight-top configurations and are provided non-sterile.

ASTM F2063 (nitinol material specification), ASTM F2129 (corrosion susceptibility), ASTM F3306 (nickel-ion release), ASTM F3044 (galvanic corrosion evaluation). Testing also followed FDA guidance on Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol.

The subject device and primary predicate (K231885) share identical intended use for foot and ankle bone fixation. Engineering analysis demonstrated the new implants do not represent a new worst-case for elastic static bending and axial pullout strength compared to the predicate. Corrosion testing showed nickel-ion release and galvanic corrosion levels significantly below FDA tolerable intake values. While bridge widths and locking features differ, these design changes do not affect safety or effectiveness. The material, sterilization method, and fundamental design approach remain equivalent to the predicate.