Cleared Traditional

MICRORAPTOR Knotless Suture Anchor (K181746) - FDA 510(k) Clearance

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

K181746 · Smith and Nephew, Inc. · Orthopedic device
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Sep 2018
Decision
88d
Days
Class 2
Risk

K181746 is an FDA 510(k) clearance for the MICRORAPTOR Knotless 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 September 28, 2018 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Smith and Nephew, Inc. devices

Submission Details

510(k) Number K181746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2018
Decision Date September 28, 2018
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 K181746.
Rotium Bioresorbable Wick
K183236 · Nanofiber Solutions, LLC · Mar 2019
HEALIX ADVANCE Anchor with DYNACORD Suture
K183506 · Medos International SARL · Feb 2019
Arthrex SwiveLock Anchors
K180768 · Arthrex, Inc. · Dec 2018
GRYPHON® Anchors with DYNACORD™ Suture
K181809 · Medos International SARL · Aug 2018
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