Alafair Biosciences · Class II · Cleared Jul 18, 2025
| K-number | K251655 |
| Device name | VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) |
| Applicant | Alafair Biosciences |
| Product code | OWW |
| Device class | Class II |
| Decision date | Jul 18, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.3300 |
VersaCoat Tendon Protector is an absorbable implant consisting of a hollow cylindrical hydrogel pellet made of alginate and hyaluronic acid, paired with an aqueous citrate wetting solution. When hydrated, it forms a viscous, flowable gel designed to protect injured tendons and surrounding tissues (ligaments, skeletal muscle) by providing a gliding surface and physical separation during healing.
The subject device and predicate device (VersaWrap Tendon Protector, K240817) are identical when implanted. Both use the same alginate-hyaluronic acid flowable matrix composition and operate via the same mechanism. Minor technological differences in packaging or delivery do not raise new safety or effectiveness questions.
ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization and irritation), ISO 10993-11 (acute systemic toxicity and pyrogenicity), ISO 10993-3 (genotoxicity), ISO 10993-6 (subchronic toxicity and muscle implantation). Endotoxin testing performed per established sampling plan.
The device demonstrates substantial equivalence because it shares identical intended use, indications for use, materials of construction (alginate-hyaluronic acid), and fundamental operating principle with the predicate. Comprehensive biocompatibility and performance testing confirmed the subject device is non-toxic, non-pyrogenic, and provides the same protective interface as the predicate. When implanted, both devices are functionally identical, establishing equivalence despite minor packaging differences.
View the full FDA submission: accessdata.fda.gov