Cleared Traditional

K213104 - Auxilock Titanium Screw-In Suture Anchor

K213104 is an FDA 510(k) clearance for Auxilock Titanium Screw-In Suture Anchor, manufactured by Auxein Medical Private Limited. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 308-day FDA review.

K213104 · Auxein Medical Private Limited · Orthopedic device
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Jul 2022
Decision
308d
Days
Class 2
Risk

K213104 is an FDA 510(k) clearance for the Auxilock Titanium Screw-In Suture Anchor. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Auxein Medical Private Limited (Sonipat, IN). The FDA issued a Cleared decision on July 29, 2022 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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. Elevated predicate reliance profile. 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 Auxein Medical Private Limited devices

FDA 510(k) Submission Details - K213104

510(k) Number K213104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2021
Decision Date July 29, 2022
Days to Decision 308 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
186d slower than avg
Panel avg: 122d · This submission: 308d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBI Device Classification - Class 2, Special Controls

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 438
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K213104.
Auxilock Draw Tight Suture-Based Anchor
K213109 · Auxein Medical Private Limited · Aug 2022
FairFix Adjustable Button System
K222169 · Medacta International S.A. · Aug 2022
Arthrex Knotless FiberTak Biceps Suture Anchor
K222161 · Arthrex, Inc. · Aug 2022
S-Core Implant System
K220901 · Subchondral Solutions, Inc. · Jul 2022
Parcus Synd-EZ SS
K221502 · Parcus Medical, LLC · Jul 2022
Mitek TIGHT-N Anchor
K221364 · Medos International SARL · Jul 2022