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FDA 510(k)

OSSIOfiber® Suture Anchor

K-Number: K254055 · 2026-02-24

ApplicantOSSIO , Ltd.
Decision Date2026-02-24
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSSIOfiber® Suture Anchor is a medical device manufactured by OSSIO , Ltd.. It received FDA 510(k) clearance on 2026-02-24 under approval number K254055. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSSIOfiber® Suture Anchor?

OSSIOfiber® Suture Anchor is a medical device that received FDA 510(k) clearance on 2026-02-24. It is manufactured by OSSIO , Ltd.. The 510(k) number is K254055.

When was OSSIOfiber® Suture Anchor approved by the FDA?

OSSIOfiber® Suture Anchor received FDA 510(k) clearance on 2026-02-24, under approval number K254055.

What company makes OSSIOfiber® Suture Anchor?

OSSIOfiber® Suture Anchor is manufactured by OSSIO , Ltd..

What is the FDA product code for OSSIOfiber® Suture Anchor?

The FDA product code for OSSIOfiber® Suture Anchor is MAI.

Related PubMed Literature

PMID: 40868376 Correlation Analysis of Suture Anchor Pull-Out Strength with Cortical Bone Thickness and Cancellous Bone Density on a Finite Element Model. Bioengineering (Basel, Switzerland) (2025)

Other Devices by OSSIO , Ltd.

K181180OSSIO™ Pin Product Family K201803OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant K193660OSSIOfiber™ Compression Screws K190652OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant K213596OSSIOfiber Compression Screw, 3.5mm K203465OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design

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Related Devices (Code: MAI)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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