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)
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.

View all T.A.G. Medical Products Corporation, Ltd. devices

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 773
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