Etex Corporation · Class II · Cleared Dec 18, 2024
| K-number | K243609 |
| Device name | EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) |
| Applicant | Etex Corporation |
| Product code | MQV |
| Device class | Class II |
| Decision date | Dec 18, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 888.3045 |
EquivaBone is a bone graft substitute combining synthetic calcium phosphate and demineralized bone matrix that resorbs and is replaced with new bone during healing. It is intended to fill bony voids or gaps in the skeletal system of the extremities, spine, and pelvis resulting from surgical creation or traumatic injury.
EquivaBone consists of Calcium Phosphate (CaP3), Carboxymethylcellulose (CMC), and Demineralized Bone Matrix (DBM). The key modification is transitioning DBM sourcing from AlloSource to LifeLink Tissue Bank. Both DBM sources are equivalent based on chemical composition, physical properties, and performance characteristics. An alternative C2C12 in vitro assay replaces the in vivo testing used for the predicate device to assess osteoinductive potential.
Not stated in this summary.
The device has identical indications for use as the primary predicate (K101557). Technological characteristics are similar, with DBM sourcing changes validated to be equivalent through comparison of chemical composition and physical properties. The new C2C12 in vitro osteoinductivity assay was correlated to the predicate's in vivo testing, demonstrating linear correlation (R² = 0.9204) and meeting acceptance criteria. Comprehensive non-clinical testing confirms functional equivalence across mechanical and biological performance parameters.
View the full FDA submission: accessdata.fda.gov