ETHICON, Inc. · Class II · Cleared Dec 22, 2025
| K-number | K252743 |
| Device name | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device |
| Applicant | ETHICON, Inc. |
| Product code | GAM |
| Device class | Class II |
| Decision date | Dec 22, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4493 |
STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices are absorbable surgical sutures made of polydioxanone with antibacterial properties (containing triclosan). Available in unidirectional and bidirectional barbed forms with needles and/or fixation loops, they are used for soft tissue approximation where absorbable sutures are appropriate, eliminating the need to tie surgical knots.
No technological changes from predicate devices. The only modification is in the Instructions for Use, where Ethicon removed the warning against use in gastrojejunal anastomoses for Roux-en-Y gastric bypass. The devices maintain identical design, materials (violet-dyed polyester and polydioxanone), antibacterial agent concentration, sterilization process (ethylene oxide), and sterility assurance level (10⁻⁶).
Not stated in this summary.
The subject device shares the same fundamental scientific technology, intended use, design, materials, packaging, labeling components, sterilization process, and sterility assurance level as its predicates (K192144 and K182873). A retrospective chart review of 145 patients undergoing robotic gastrojejunal anastomosis showed no anastomotic leakage, bleeding, or intra-abdominal infection within 30 days, supporting removal of the gastric bypass warning and confirming substantial equivalence.
View the full FDA submission: accessdata.fda.gov