OSSIOfiber® Suture Anchor— 510(k) K254055
Substantially EquivalentOSSIO , Ltd.
FDA 510(k) clearance K254055 for OSSIOfiber® Suture Anchor, Substantially Equivalent on 2026-02-24. Applicant: OSSIO , Ltd.. Device class: 2.
Summary
OSSIO's OSSIOfiber® Suture Anchor is filed under product code MAI, biodegradable soft tissue fixation fastener. The record doesn't describe the anchor beyond its name and that code name.
Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).
OSSIO filed from Caesarea, Israel. Review took 69 calendar days (December 17, 2025 to February 24, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- OSSIO , Ltd.
- Product code
- Product code MAI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Caesarea, IL
Recent devices under product code MAI
view allMore clearances from OSSIO , Ltd.
view allAdverse events under product code MAI
product code MAI- Injury
- 1,948
- Malfunction
- 8,580
- Total
- 10,528
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.