Cleared Traditional

Accelerate Compression Screw System-Small Product Code ACC-S (K230946) - FDA 510(k) Clearance

Also marketed or referenced as:
Accelerate Compression Screw System-Medium Product Code ACC-M Accelerate Compression Screw System-Large Product Code ACC-L

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

K230946 · Trax Surgical · Orthopedic device
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Sep 2023
Decision
164d
Days
Class 2
Risk

K230946 is an FDA 510(k) clearance for the Accelerate Compression Screw System-Small Product Code ACC-S. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Trax Surgical (Stoughton, US). The FDA issued a Cleared decision on September 15, 2023 after a review of 164 days - an extended review cycle.

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 Trax Surgical devices

Submission Details

510(k) Number K230946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2023
Decision Date September 15, 2023
Days to Decision 164 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
42d slower than avg
Panel avg: 122d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 404
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K230946.
APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension
K232251 · Medartis AG · Nov 2023
MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices
K231231 · Paragon 28, Inc. · Oct 2023
Intraosseous Fusion Device System
K231649 · Auxano Medical, LLC · Sep 2023
TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System
K231504 · Vilex, LLC · Sep 2023
Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
K231819 · Innovate Orthopaedics Limited · Sep 2023
Nexis® compressive screws
K223468 · Novastep · Aug 2023