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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / November 2025 / K251555

510(k) cleared

Ultra Compression Screw System

Pace Surgical · Nov 6, 2025 · K251555

FDA cleared the Ultra Compression Screw System from Pace Surgical on Nov 6, 2025 under K251555, a traditional 510(k). The device falls under product code HWC, Screw, Fixation, Bone, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on May 21, 2025. The decision came 169 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Pace Surgical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251555?

K251555 is the FDA 510(k) for Ultra Compression Screw System, submitted by Pace Surgical. FDA's decision date was Nov 6, 2025, under product code HWC (Screw, Fixation, Bone).

Who makes the Ultra Compression Screw System?

Pace Surgical, based in Malvern, PA, is the applicant of record for K251555.

How long did the K251555 review take?

FDA received the submission on May 21, 2025 and issued its decision on Nov 6, 2025, 169 days later.

← All decisions in November 2025