Cleared Traditional

K180361 - MICRORAPTOR REGENESORB Suture Anchor (FDA 510(k) Clearance)

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

K180361 · Smith and Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
110d
Days
Class 2
Risk

K180361 is an FDA 510(k) clearance for the MICRORAPTOR REGENESORB Suture Anchor. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Smith and Nephew, Inc. (Cordova, US). The FDA issued a Cleared decision on May 30, 2018 after a review of 110 days - within the typical 510(k) review window.

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 Smith and Nephew, Inc. devices

Submission Details

510(k) Number K180361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2018
Decision Date May 30, 2018
Days to Decision 110 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 122d · This submission: 110d
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 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 K180361.
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
OSSIOfiber® Suture Anchor
K251309 · OSSIO , Ltd. · May 2025