BETA
Developer of the RapidFix all-suture dual-anchor system for tendon and ligament repair.
SutureTech develops orthopedic devices for soft-tissue fixation. Its RapidFix platform combines an all-suture dual-anchor construct with a horizontal mattress configuration, designed for tendon and ligament repair through arthroscopic and open surgical approaches.
The FDA cleared the All-Suture Dual Anchor System under K250095 on September 5, 2025. The company markets the platform as RapidFix. Product materials describe a three-step insertion and repair workflow; those materials do not independently establish better long-term healing or faster recovery than alternative devices.
Founder and CEO Oke Anakwenze leads the company, with engineering, finance and clinical product functions identified on its team page. Its commercial audience is orthopedic surgeons and the facilities and distribution partners supporting soft-tissue repair procedures. Broader adoption, revenue and financing totals remain unconfirmed in this profile.
RapidFix has FDA 510(k) clearance K250095. The company reported first surgical use in March 2026. That confirms an early commercial milestone, without establishing broad adoption or authorizing every future repair application. [9][8][2][10][13][1]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [6][4]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
All-suture dual-anchor system designed for soft-tissue-to-bone fixation in arthroscopic and open procedures. [9][8]
FDA-clearedCommercially offered; exact model and country availability should be confirmed with the manufacturer.
Company announced first surgical use on March 31, 2026 following 2025 clearance. Broader availability and uptake remain to be verified. [9][11][12]
Company reported first clinical use in a lateral extra-articular tenodesis knee procedure. A first case is not evidence of broad adoption or comparative outcomes. [12]
FDA recorded a substantially equivalent decision for the system marketed as RapidFix. [8]
Accessed 10/20/2026