meddevicedb.com FDA Device Reference

Iconix Knotless T

K262677 Class II Special
Decision Date
2026-08-27
Sponsor / Applicant
Riverpoint Medical

Technical Specification

510(k) Submission ID K262677
Product Code MBI
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3040
Decision Date 2026-08-27
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Iconix Knotless T received FDA 510(k) clearance under submission number K262677, sponsored by Riverpoint Medical. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2026-08-27.

Classification & Regulation

This clearance is catalogued under FDA product code MBI and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.