Cleared Traditional

K203029 - Auxilock Titanium Interference Screw

K203029 is an FDA 510(k) clearance for Auxilock Titanium Interference Screw, manufactured by Auxein Medical Private Limited. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K203029 · Auxein Medical Private Limited · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
322d
Days
Class 2
Risk

K203029 is an FDA 510(k) clearance for the Auxilock Titanium Interference Screw. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Auxein Medical Private Limited (Sonipat, IN). The FDA issued a Cleared decision on August 20, 2021 after a review of 322 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 - K203029

510(k) Number K203029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2020
Decision Date August 20, 2021
Days to Decision 322 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
200d slower than avg
Panel avg: 122d · This submission: 322d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 680
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K203029.
ChM 4.5mm Cortical screws
K210490 · Chm Sp. Z O.O. · Oct 2021
Nexta PEEK Hammertoe Correction System
K211996 · Nextremity Solutions, Inc. · Sep 2021
Auxein Nailing System
K210792 · Auxein Medical Private Limited · Aug 2021
PAO Cortical Screw
K211435 · Medacta International S.A. · Aug 2021
TriMed Threaded Intramedullary Nail System
K211783 · TriMed, Inc. · Aug 2021
Cannulated Fasteners and Nuts
K211290 · OsteoCentric Technologies · Aug 2021