| K-number | K253145 |
| Device name | Pre-Sutured Tendon |
| Applicant | Rti Surgical, Inc. |
| Product code | GAT |
| Device class | Class II |
| Decision date | Oct 22, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.5000 |
The Pre-Sutured Tendon is a donated human nonbone tendon pre-sutured with sterile ultra-high-molecular-weight polyethylene (UHMWPE) nonabsorbable sutures, processed via the BioCleanse Tissue Sterilization Process. It is offered as a single strand or quadruple strand and is intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction for single patient use only.
There are no technological differences between the subject and predicate device. Minor dimensional differences exist in length and diameter ranges, and gracilis tendon has been added as a source tendon option. These differences do not affect intended use, performance, safety, design, or function.
Not stated in this summary.
The Pre-Sutured Tendon is substantially equivalent to predicate device K230036 based on identical indications for use, aseptic processing, design, materials, and function. Bench tests (ultimate load, cyclic displacement, suture pull-out) confirmed the expanded dimensions and gracilis source tendon meet the same performance requirements as the predicate, and non-clinical testing (packaging validation, tissue sterilization, viral inactivation, shelf-life, biocompatibility, and bacterial endotoxin) demonstrated substantial equivalence.
View the full FDA submission: accessdata.fda.gov