Strut Suture; No-Tie Button— 510(k) K253693
Substantially EquivalentRiverpoint Medical, LLC
FDA 510(k) clearance K253693 for Strut Suture; No-Tie Button, Substantially Equivalent on 2026-03-11. Applicant: Riverpoint Medical, LLC. Device class: 2.
Summary
Riverpoint Medical's record covers two products, Strut Suture and No-Tie Button. Both are filed under MBI, nondegradable soft tissue fixation fasteners.
Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Riverpoint Medical filed from Portland, Oregon. Review took 110 calendar days (November 21, 2025 to March 11, 2026).
Clearance details
- Applicant
- Riverpoint Medical, LLC
- Product code
- Product code MBI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portland, OR, US
Recent devices under product code MBI
view allMore clearances from Riverpoint Medical, LLC
view allAdverse events under product code MBI
product code MBI- Injury
- 3,163
- Malfunction
- 13,006
- Other
- 2
- Total
- 16,171
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.