| K-number | K252647 |
| Device name | Tapestry Biointegrative Implant |
| Applicant | Embody, Inc. |
| Product code | OWY |
| Device class | Class II |
| Decision date | Sep 19, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.3300 |
The Tapestry Biointegrative Implant is a sterile, single-use collagen and poly(D,L-lactide) device designed to function as a protective layer between tendons and surrounding tissues. It is indicated for management and protection of tendon injuries where there has been no substantial loss of tendon tissue, and is supplied as a standalone implant, in an insertion sleeve, or on an introducer for arthroscopic delivery.
The subject device has broadened specifications for density and thickness compared to the predicate device (K212306). No other design changes were made. Both devices share the same intended use, indication for use, and fundamental collagen-based scientific technology.
Not stated in this summary.
The predetermined acceptance criteria that supported the predicate device were met for the subject device. Non-clinical testing—including mechanical testing (tensile strength and suture retention strength) and porosity analysis—demonstrated results substantially equivalent to prior testing. The density and thickness changes are considered minor modifications that do not alter the device's safety and effectiveness profile, as confirmed by risk analysis and verification/validation activities.
View the full FDA submission: accessdata.fda.gov