Cleared Traditional

K231649 - Intraosseous Fusion Device System

K231649 is an FDA 510(k) clearance for Intraosseous Fusion Device System, manufactured by Auxano Medical, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K231649 · Auxano Medical, LLC · Orthopedic device
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Sep 2023
Decision
115d
Days
Class 2
Risk

K231649 is an FDA 510(k) clearance for the Intraosseous Fusion Device System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Auxano Medical, LLC (Brecksville, US). The FDA issued a Cleared decision on September 29, 2023 after a review of 115 days - within the typical 510(k) review window.

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. 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 Auxano Medical, LLC devices

FDA 510(k) Submission Details - K231649

510(k) Number K231649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2023
Decision Date September 29, 2023
Days to Decision 115 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
7d faster than avg
Panel avg: 122d · This submission: 115d
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 K231649.
Cannulated Screw System
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MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices
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K230946 · Trax Surgical · Sep 2023
TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System
K231504 · Vilex, LLC · Sep 2023
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K231819 · Innovate Orthopaedics Limited · Sep 2023