Theramicro · Class II · Cleared May 30, 2025
| K-number | K251063 |
| Device name | TekBrace Solo Soft Tissue Reinforcement Device |
| Applicant | Theramicro |
| Product code | QUW |
| Device class | Class II |
| Decision date | May 30, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.3300 |
The TekBrace Solo Soft Tissue Reinforcement Device is a single-use surgical implant made of non-absorbable polyester (PET) designed to reinforce soft tissues during tendon and ligament repair surgery. It is intended to support repair of structures such as the rotator cuff, patellar tendon, Achilles tendon, and various ligaments, but does not replace normal body structure or provide full mechanical strength—sutures and fixation devices provide the primary mechanical support.
The device features a central tubular weave tape that tapers down to cords at both ends, is manufactured from non-absorbable polyethylene terephthalate (PET/polyester), incorporates Cottony II green PET suture for pocket location visibility, and is available in two sizes with pockets providing access to the inside of the tubular section.
Not stated in this summary.
The TekBrace Solo is substantially equivalent to the Xiros Poly-Tape/Infinity-Lock predicate devices because it has identical indications for use, the same material composition (PET), identical design principles (central tubular section tapering to cords), and equivalent manufacturing processes. Performance testing demonstrated equivalent or superior tensile strength, fixation strength, and fatigue resistance compared to predicates, with endotoxin testing within acceptable limits, confirming no new safety or effectiveness questions are raised.
View the full FDA submission: accessdata.fda.gov