Cleared Traditional

K213104 - Auxilock Titanium Screw-In Suture Anchor (FDA 510(k) Clearance)

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

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

Submission Details

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.

Device Classification

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 590
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K213104.
ArthroTAK Tendon Anchor Kit
K252635 · ArthroTAK, LLC · May 2026
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Arthrex FiberTak Suture Anchor
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Grappler Suture Anchor PCFD Tether System
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SINEFIX
K254176 · BAAT Medical Products B.V. · Mar 2026
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K251750 · Trax Surgical, Inc. · Mar 2026