Cleared Traditional

MICRORAPTOR REGENESORB Suture Anchor (K180361) - 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
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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

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
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.

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 122
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