Cleared Traditional

Ultra? Compression Screw System

K251555 · Pace Surgical · Orthopedic

Nov 2025

Decision

169d

Days

Class 2

Risk

About This 510(k) Submission

K251555 is an FDA 510(k) clearance for the Ultra? Compression Screw System, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Pace Surgical (Malvern, US). The FDA issued a Cleared decision on November 6, 2025, 169 days after receiving the submission on May 21, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K251555 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 21, 2025
Decision Date	November 06, 2025
Days to Decision	169 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF