OsteoSinter® EVANS and COTTON wedges and related accessories

The OsteoSinter® EVANS and COTTON wedges are sterile, single-use porous titanium implants designed for internal bone fixation of foot fractures, fusions, and osteotomies. They are indicated for specific foot procedures including opening wedge osteotomies for hallux valgus, medial cuneiform/cotton osteotomies, lateral column lengthening, and metatarsal/cuneiform arthrodesis, used with ancillary bone fixation and not for spinal applications.

The subject device uses powder metal sintering technology to create a porous CP titanium wedge with 62-66% total porosity, pore cell sizes averaging 532 µm, interconnected pores averaging 270 µm, and an apparent elastic modulus of 2.8 GPa. Performance testing showed static/dynamic compressive strength, abrasion resistance of 0.32% weight loss at 1000 N, friction coefficient of 1.22±0.28, and compressive fatigue limit exceeding 11.3 MPa at 5 million cycles without failure.

Not stated in this summary. The document references bench performance tests including static compressive strength, dynamic compressive strength, abrasion, and friction testing, along with biocompatibility testing and animal/in-vivo testing, but does not cite specific standards (ISO, ASTM, IEC, etc.).

The subject device is substantially equivalent because it matches the predicate devices (BIOFOAM® K142724 and Arthrex BioSync® K151256) in material composition (CP titanium), intended use (foot bone fixation with ancillary fixation), physical properties (porosity 62-66% vs 60-70% and 58%, pore sizes and elastic modulus within equivalent ranges), and performance characteristics (abrasion and friction results equivalent to K151256, fatigue strength equivalent to K151256). No new safety or effectiveness concerns were identified based on the non-clinical testing data provided.