Cleared Traditional

K250536 - MetaFore Small Screw System

K250536 is an FDA 510(k) clearance for MetaFore Small Screw System, manufactured by Extremity Medical, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K250536 · Extremity Medical, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
226d
Days
Class 2
Risk

K250536 is an FDA 510(k) clearance for the MetaFore Small Screw System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Extremity Medical, LLC (Parsippany, US). The FDA issued a Cleared decision on October 8, 2025 after a review of 226 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 Extremity Medical, LLC devices

FDA 510(k) Submission Details - K250536

510(k) Number K250536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2025
Decision Date October 08, 2025
Days to Decision 226 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
104d slower than avg
Panel avg: 122d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 927
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K250536.
Tyber Medical Trauma Screw
K252901 · Tyber Medical, LLC · Dec 2025
Ultra™ Compression Screw System
K251555 · Pace Surgical · Nov 2025
Eleganz IM Threaded Nail System (IM Threaded Nail System)
K252312 · Dev4 · Oct 2025
Cannulated Screw and Kirschner (K wire) System
K252758 · Orthonovis, Inc. · Oct 2025
CurvaFix Low Profile System
K252019 · Curvafix, Inc. · Aug 2025
Phoenix Sinus Tarsi Stent System
K251382 · Astra Orthomed, Inc. · Aug 2025