Paragon 28, Inc. · Class II · Cleared Mar 17, 2026
| K-number | K253886 |
| Device name | Grappler Suture Anchor PCFD Tether System |
| Applicant | Paragon 28, Inc. |
| Product code | MBI |
| Device class | Class II |
| Decision date | Mar 17, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The Grappler Suture Anchor PCFD Tether System is a soft tissue-to-bone fixation device consisting of two PEEK suture anchors connected by UHMWPE suture tape. It is intended for foot and ankle repair, including medial stabilization, hindfoot repair, and ligament repair to address Progressive Collapsing Foot Deformity (PCFD).
The device contains two PEEK cortical buttons (talar anchor ⌀4.5mm, calcaneal anchor ⌀3.5mm, each 12mm long) that extend into cortical bone. The suture is a doubled-over USP 2 equivalent tape. The subject device's key technological difference is the orientation of button placement in different planes to accommodate PCFD-specific surgical technique.
FDA recognized standards for bacterial endotoxin testing. Testing included suture abrasion, dynamic axial dissociation, static and fatigue tensile testing evaluating load and displacement.
View the full FDA submission: accessdata.fda.gov