| K-number | K250109 |
| Device name | TYBR Collagen Gel |
| Applicant | Tybr Health |
| Product code | OWY |
| Device class | Class II |
| Decision date | Jun 6, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.3300 |
TYBR Collagen Gel is a naturally-derived collagenous semi-permeable barrier device that conforms to the application site and degrades within 30 days. It is indicated for management and protection of tendon injuries with no substantial loss of tendon tissue, and may also be used for protection of surrounding tissues such as skeletal muscle and ligament. The device includes a blue color additive for visualization and an applicator for controlled delivery.
TYBR Collagen Gel is composed of collagen and forms a gel when applied to the implantation site, whereas the primary predicate VersaWrap is composed of cross-linked calcium alginate and glycosaminoglycan (GAG). Both products are resorbable and form gels. TYBR includes a color additive and an applicator for implantation, while VersaWrap requires hand application. The secondary predicate is also collagen-based.
Not stated in this summary.
Although TYBR differs from the primary predicate in material composition (collagen vs. alginate-GAG), both products share the same intended use and indications for tendon repair and protection of surrounding tissues. Both are resorbable gels. The differences in material and application method do not raise safety or effectiveness concerns, supported by cadaveric biomechanical testing showing no negative impact from under- or over-application of the gel, and animal performance studies in a chicken flexor tendon repair model demonstrating equivalent tendon rupture strength, histopathology, gross pathology, and range of motion compared to VersaWrap.
View the full FDA submission: accessdata.fda.gov