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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / July 2026 / K261406

510(k) cleared

Versalock Proximal Tibial Plating System

GM Dos Reis Industria e Comercio Ltda. · Jul 21, 2026 · K261406

FDA cleared the Versalock Proximal Tibial Plating System from GM Dos Reis Industria e Comercio Ltda. on Jul 21, 2026 under K261406, 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 29, 2026. The decision came 83 days later, inside the 90 FDA-day goal for a 510(k).

GM Dos Reis Industria e Comercio Ltda. has 6 other decisions in the tracker over the last 12 months: K253910 (Stitch - Suture Wires and Tapes), K262537 (Versalock Sterile Plating System), K260390 (Super Upper Limbs Versalock Plating System), K254188 (Meniscus Versaflex).

Questions & Answers

What did FDA clear under K261406?

K261406 is the FDA 510(k) for Versalock Proximal Tibial Plating System, submitted by GM Dos Reis Industria e Comercio Ltda.. FDA's decision date was Jul 21, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the Versalock Proximal Tibial Plating System?

GM Dos Reis Industria e Comercio Ltda., based in Campinas, is the applicant of record for K261406.

How long did the K261406 review take?

FDA received the submission on Apr 29, 2026 and issued its decision on Jul 21, 2026, 83 days later.

← All decisions in July 2026

Sources