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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 / December 2025 / K251050

510(k) cleared

Pectus Versa System

Gm Dos Reis Industria E Comercio · Dec 19, 2025 · K251050

FDA cleared the Pectus Versa System from Gm Dos Reis Industria E Comercio on Dec 19, 2025 under K251050, a traditional 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Apr 3, 2025. The decision came 260 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Gm Dos Reis Industria E Comercio has 4 other decisions in the tracker over the last 12 months: K261406 (Versalock Proximal Tibial Plating System), K260390 (Super Upper Limbs Versalock Plating System), K254188 (Meniscus Versaflex), K252664 (GMReis Suture Anchors).

Questions & Answers

What did FDA clear under K251050?

K251050 is the FDA 510(k) for Pectus Versa System, submitted by Gm Dos Reis Industria E Comercio. FDA's decision date was Dec 19, 2025, under product code HRS (Plate, Fixation, Bone).

Who makes the Pectus Versa System?

Gm Dos Reis Industria E Comercio, based in Campinas, is the applicant of record for K251050.

How long did the K251050 review take?

FDA received the submission on Apr 3, 2025 and issued its decision on Dec 19, 2025, 260 days later.

← All decisions in December 2025

Sources