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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 / October 2025 / K251686

510(k) cleared

Tornier Humeral Reconstruction System Max (Tornier HRS Max)

Tornier, Inc. · Oct 30, 2025 · K251686

FDA cleared the Tornier Humeral Reconstruction System Max (Tornier HRS Max) from Tornier, Inc. on Oct 30, 2025 under K251686, a traditional 510(k). The device falls under product code KWT, Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented, regulated at 21 CFR 888.3650 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 2, 2025. The decision came 150 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Tornier, Inc. has 2 other decisions in the tracker over the last 12 months: K260721 (Tornier Perform Advanced Glenoid), K252788 (Tornier Perform Reversed Monopost Glenoid (Perform Mono)).

Questions & Answers

What did FDA clear under K251686?

K251686 is the FDA 510(k) for Tornier Humeral Reconstruction System Max (Tornier HRS Max), submitted by Tornier, Inc.. FDA's decision date was Oct 30, 2025, under product code KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented).

Who makes the Tornier Humeral Reconstruction System Max (Tornier HRS Max)?

Tornier, Inc., based in Bloomington, MN, is the applicant of record for K251686.

How long did the K251686 review take?

FDA received the submission on Jun 2, 2025 and issued its decision on Oct 30, 2025, 150 days later.

← All decisions in October 2025

Sources