| K-number | K250997 |
| Device name | Integrity Implant |
| Applicant | Anika Therapeutics, Inc. |
| Product code | OWX |
| Device class | Class II |
| Decision date | Jun 17, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.3300 |
The Integrity™ Implant is a knitted porous mesh made of resorbable Hyaff-11 and non-resorbable polyethylene terephthalate (PET) fibers. It is designed to provide an augmentation layer over injured tendons and is indicated for management and protection of tendon injuries where there has been no substantial loss of tendon tissue. The device is implanted via standard open or arthroscopic surgical procedures and secured using fixation.
The subject device is identical to the predicate in material composition (Hyaff + PET), partial resorbability, packaging (tray in peel pouch), sterilization method (gamma irradiation), and principle of operation. The only difference is the addition of two larger sizes: 25mm × 60mm and 40mm × 60mm, compared to the predicate's 20mm × 25mm and 25mm × 30mm sizes.
Not stated in this summary.
Substantial equivalence is established through identical indications for use, materials, manufacturing process, and sterilization parameters. Performance testing on the new sizes (dimensions, thickness, basis weight/density, stiffness, compliance, and sterility) demonstrated that the larger dimensions maintain equivalent functionality. Since the subject and predicate devices share the same material composition and the original animal study and biocompatibility data from the predicate remain applicable, the size differences alone do not introduce new safety or effectiveness questions.
View the full FDA submission: accessdata.fda.gov