Adaptos®Fuse Bone Graft

Adaptos®Fuse Bone Graft is a bioactive bone void filler composed of poly(L-lactide-co-ε-caprolactone), tricalcium phosphate, and bioactive glass, supplied as granules in syringes. It is intended for use in bony voids or gaps created by surgery or trauma in the spine (posterolateral, interbody) and pelvis, and must be mixed with autograft prior to placement where it resorbs and is replaced with new bone during healing.

Adaptos®Fuse is composed of PLCL, TCP, and bioactive glass, whereas the primary predicate NovaBone Putty contains 70% bioactive glass granules, 30% polyethylene glycol, and glycerin binder. Unlike some predicates, Adaptos®Fuse requires mandatory mixing with autograft, making its indication narrower. Both devices are resorbable and support bone formation, but differ in material composition and delivery mechanism.

The submission references ISO 13485 clauses 7.3 (Design controls), 8.3 (Nonconforming product), and 8.5 (Corrective and preventative action). Testing included device characterization, sterilization, shelf-life, endotoxin, elemental impurity, in vitro degradation, bioactivity, pyrogenicity, and biocompatibility studies, though specific ASTM or IEC standards are not explicitly named in this summary.

Adaptos®Fuse has the same intended use as predicates (NovaBone Putty, Synthes chronOS) and identical specific indications for posterolateral spine and pelvis fusion. Although material composition differs, these differences do not raise new safety or effectiveness questions. Animal performance testing in a rabbit posterolateral spine fusion model demonstrated Adaptos®Fuse achieved higher fusion scores than NovaBone Putty and was equivalent to autograft control, supporting substantial equivalence.