Cleared Special

K251309 - OSSIOfiber® Suture Anchor (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K251309 · OSSIO , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
29d
Days
Class 2
Risk

K251309 is an FDA 510(k) clearance for the OSSIOfiber® Suture Anchor. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by OSSIO , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on May 27, 2025 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all OSSIO , Ltd. devices

Submission Details

510(k) Number K251309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2025
Decision Date May 27, 2025
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MAI Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

Mcra, LLC
Dave McGurl

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MAI Fastener, Fixation, Biodegradable, Soft Tissue

All 218
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K251309.
SF Push-in Anchor
K260294 · Surgical Fusion Technologies GmbH · Mar 2026
OSSIOfiber® Suture Anchor
K254055 · OSSIO , Ltd. · Feb 2026
Biosteon® Screw
K251680 · Biocomposites, Ltd. · Feb 2026
BioBrace® Extra-Articular Ligament Augmentation Kit
K252946 · Conmed Corporation · Oct 2025
OSSIOfiber® Interference Screw
K252022 · OSSIO , Ltd. · Aug 2025
Knotilus+ Biocomposite Knotless Anchor
K250544 · Stryker Endoscopy · May 2025