Cleared Traditional

K243943 - TriMed® Compression Screws

K243943 is an FDA 510(k) clearance for TriMed Compression Screws, manufactured by TriMed, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K243943 · TriMed, Inc. · Orthopedic device
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Apr 2025
Decision
111d
Days
Class 2
Risk

K243943 is an FDA 510(k) clearance for the TriMed® Compression Screws. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by TriMed, Inc. (Santa Clarita, US). The FDA issued a Cleared decision on April 10, 2025 after a review of 111 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 TriMed, Inc. devices

FDA 510(k) Submission Details - K243943

510(k) Number K243943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2024
Decision Date April 10, 2025
Days to Decision 111 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 122d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

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 919
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K243943.
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K250613 · Nvision Biomedical Technologies, Inc. · Apr 2025
TITANEX Screw Systems
K250304 · Vilex, LLC · Mar 2025
Caliber Intramedullary Fixation System
K242896 · Nvision Biomedical Technologies · Feb 2025