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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 / July 2026 / K261271

510(k) cleared

Cable-Ready® Cable Grip System

Pioneer Surgical Technology, Inc. · Jul 16, 2026 · K261271

FDA cleared the Cable-Ready® Cable Grip System from Pioneer Surgical Technology, Inc. on Jul 16, 2026 under K261271, a traditional 510(k). The device falls under product code JDQ, Cerclage, Fixation, regulated at 21 CFR 888.3010 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Apr 17, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Pioneer Surgical Technology, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261271?

K261271 is the FDA 510(k) for Cable-Ready® Cable Grip System, submitted by Pioneer Surgical Technology, Inc.. FDA's decision date was Jul 16, 2026, under product code JDQ (Cerclage, Fixation).

Who makes the Cable-Ready® Cable Grip System?

Pioneer Surgical Technology, Inc., based in Marquette, MI, is the applicant of record for K261271.

How long did the K261271 review take?

FDA received the submission on Apr 17, 2026 and issued its decision on Jul 16, 2026, 90 days later.

← All decisions in July 2026