Cleared Special

K262344 - Large Compression Screws

K262344 is an FDA 510(k) clearance for Large Compression Screws, manufactured by TriMed, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 33-day FDA review.

K262344 · TriMed, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
33d
Days
Class 2
Risk

K262344 is an FDA 510(k) clearance for the Large 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 August 12, 2026 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K262344

510(k) Number K262344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2026
Decision Date August 12, 2026
Days to Decision 33 days
Submission Type Special
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
89d faster than avg
Panel avg: 122d · This submission: 33d
Pathway characteristics
Modification to existing cleared device.

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 1057
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K262344.
F.A.S.T Screw
K254280 · Steps Ortho · Sep 2026
ActivaScrew™ Cannulated COM
K261057 · Bioretec, Ltd. · Sep 2026
OsteoCoil™ GT Active Compression System
K260106 · Flower Orthopedics Corporation DBA Conventus Flower Orthoped · Aug 2026
GFS - Sterile Screws and Top Hat
K253858 · T.A.G. Medical Products Corporation, Ltd. · Aug 2026
Lapidus Screw Kit
K262075 · Relja Innovations, LLC · Jul 2026
Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System
K260809 · Arthrex, Inc. · Jun 2026
K262344 · Large Compression Screws
Download PDF FDA Summary TriMed, Inc.