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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 / K260721

510(k) cleared

Tornier Perform Advanced Glenoid

Tornier, Inc. · Jul 22, 2026 · K260721

FDA cleared the Tornier Perform Advanced Glenoid from Tornier, Inc. on Jul 22, 2026 under K260721, a traditional 510(k). The device falls under product code KWS, Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented, regulated at 21 CFR 888.3660 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Mar 5, 2026. The decision came 139 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: K252788 (Tornier Perform Reversed Monopost Glenoid (Perform Mono)), K251686 (Tornier Humeral Reconstruction System Max (Tornier HRS Max)).

Questions & Answers

What did FDA clear under K260721?

K260721 is the FDA 510(k) for Tornier Perform Advanced Glenoid, submitted by Tornier, Inc.. FDA's decision date was Jul 22, 2026, under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented).

Who makes the Tornier Perform Advanced Glenoid?

Tornier, Inc., based in Bloomington, MN, is the applicant of record for K260721.

How long did the K260721 review take?

FDA received the submission on Mar 5, 2026 and issued its decision on Jul 22, 2026, 139 days later.

← All decisions in July 2026

Sources