Cleared Traditional

K180361 - MICRORAPTOR REGENESORB Suture Anchor

K180361 is an FDA 510(k) clearance for MICRORAPTOR REGENESORB Suture Anchor, manufactured by Smith and Nephew, Inc.. The device is a Class 2 Orthopedic device with product code MAI cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K180361 · Smith and Nephew, Inc. · Orthopedic device
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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

FDA 510(k) Submission Details - K180361

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
Combination Product No
PCCP Authorized No
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.

MAI Device Classification - Class 2, Special Controls

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 171
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K180361.
FIXIT / ComposiTCP Threaded Anchor System
K180960 · S.B.M. Sas Sciences For Bio Materials · Jul 2018
CuffLink Implant System Biocomposite
K180763 · Conmed Corporation · Jul 2018
Knotless SutureTak Anchors
K180594 · Arthrex, Inc. · Jun 2018
Arthrex FastThread Interference Screw
K180662 · Arthrex, Inc. · May 2018
HEALIX ADVANCE KNOTLESS BR Anchor
K180101 · Medos International SARL · May 2018
HEALIX ADVANCE Anchor with DYNACORD Suture
K173859 · Medos International SARL · Apr 2018