Cleared Special

K253858 - GFS - Sterile Screws and Top Hat

K253858 is an FDA 510(k) clearance for GFS - Sterile Screws and Top Hat, manufactured by T.A.G. Medical Products Corporation, Ltd.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 245-day FDA review.

K253858 · T.A.G. Medical Products Corporation, Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
245d
Days
Class 2
Risk

K253858 is an FDA 510(k) clearance for the GFS - Sterile Screws and Top Hat. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by T.A.G. Medical Products Corporation, Ltd. (Gaaton Northern, IL). The FDA issued a Cleared decision on August 5, 2026 after a review of 245 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. 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. Standard predicate reliance. 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 - K253858

510(k) Number K253858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2025
Decision Date August 05, 2026
Days to Decision 245 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
123d slower than avg
Panel avg: 122d · This submission: 245d
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 K253858.
ActivaScrew™ Cannulated COM
K261057 · Bioretec, Ltd. · Sep 2026
OsteoCoil™ GT Active Compression System
K260106 · Flower Orthopedics Corporation DBA Conventus Flower Orthoped · Aug 2026
Large Compression Screws
K262344 · TriMed, Inc. · 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
VEOFIX Snap Off Screw
K253108 · Steps Ortho · Jun 2026
K253858 · GFS - Sterile Screws and Top Hat
Download PDF FDA Summary T.A.G. Medical Produc…