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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 / January 2026 / K253713

510(k) cleared

Arthrex Variable Angle (VA) Proximal Tibia Plating System

Arthrex, Inc. · Jan 21, 2026 · K253713

FDA cleared the Arthrex Variable Angle (VA) Proximal Tibia Plating System from Arthrex, Inc. on Jan 21, 2026 under K253713, 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 Nov 24, 2025. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

Arthrex, Inc. has 8 other decisions in the tracker over the last 12 months: K262357 (Arthrex Bioabsorbable PushLock Suture Anchors), K260624 (Arthrex Radial Head Replacement System), K260018 (Arthrex FiberButton), K260809 (Arthrex Sterile VAL and VAL KreuLock Compression Screw System).

Questions & Answers

What did FDA clear under K253713?

K253713 is the FDA 510(k) for Arthrex Variable Angle (VA) Proximal Tibia Plating System, submitted by Arthrex, Inc.. FDA's decision date was Jan 21, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the Arthrex Variable Angle (VA) Proximal Tibia Plating System?

Arthrex, Inc., based in Naples, FL, is the applicant of record for K253713.

How long did the K253713 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Jan 21, 2026, 58 days later.

← All decisions in January 2026