Cleared Traditional

K213415 - OSSIOfiber Suture Anchor (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213415 · OSSIO , Ltd. · Orthopedic device
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Mar 2022
Decision
160d
Days
Class 2
Risk

K213415 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 March 28, 2022 after a review of 160 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all OSSIO , Ltd. devices

Submission Details

510(k) Number K213415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2021
Decision Date March 28, 2022
Days to Decision 160 days
Submission Type Traditional
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
38d slower than avg
Panel avg: 122d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
David 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 K213415.
SF Push-in Anchor
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K251680 · Biocomposites, Ltd. · Feb 2026
BioBrace® Extra-Articular Ligament Augmentation Kit
K252946 · Conmed Corporation · Oct 2025
OSSIOfiber® Interference Screw
K252022 · OSSIO , Ltd. · Aug 2025
OSSIOfiber® Suture Anchor
K251309 · OSSIO , Ltd. · May 2025