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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 / June 2026 / K260102

510(k) cleared

Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System

Stryker Corporation (Tornier, Inc.) · Jun 12, 2026 · K260102

FDA cleared the Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System from Stryker Corporation (Tornier, Inc.) on Jun 12, 2026 under K260102, a traditional 510(k). The device falls under product code PHX, Shoulder Prosthesis, Reverse Configuration, regulated at 21 CFR 888.3660 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jan 13, 2026. The decision came 150 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Stryker Corporation (Tornier, Inc.) has one other decision in the tracker over the last 12 months: K253674 (Blueprint Patient-Specific Instrumentation).

Questions & Answers

What did FDA clear under K260102?

K260102 is the FDA 510(k) for Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System, submitted by Stryker Corporation (Tornier, Inc.). FDA's decision date was Jun 12, 2026, under product code PHX (Shoulder Prosthesis, Reverse Configuration).

Who makes the Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System?

Stryker Corporation (Tornier, Inc.), based in Bloomington, MN, is the applicant of record for K260102.

How long did the K260102 review take?

FDA received the submission on Jan 13, 2026 and issued its decision on Jun 12, 2026, 150 days later.

← All decisions in June 2026

Sources