Iconix Knotless T— 510(k) K262677
Substantially EquivalentRiverpoint Medical
FDA 510(k) clearance K262677 for Iconix Knotless T, Substantially Equivalent on 2026-08-27. Applicant: Riverpoint Medical. Device class: 2.
Summary
Riverpoint Medical filed the Iconix Knotless T under product code MBI, nondegradable soft tissue fixation fasteners. The record has no description beyond the name and that code.
Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel, and it came in as a Special 510(k).
Riverpoint filed from Portland, Oregon. Review took 28 calendar days (July 30 to August 27, 2026) and ended in a substantially equivalent decision.
Clearance details
- Applicant
- Riverpoint Medical
- 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
- Special
- Location
- Portland, OR, US
Recent devices under product code MBI
view allMore clearances from Riverpoint Medical
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.