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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 / April 2026 / K253674

510(k) cleared

Blueprint Patient-Specific Instrumentation

Stryker Corporation (Tornier, S.A.S.) · Apr 3, 2026 · K253674

FDA cleared the Blueprint Patient-Specific Instrumentation from Stryker Corporation (Tornier, S.A.S.) on Apr 3, 2026 under K253674, 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 Nov 21, 2025. The decision came 133 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Stryker Corporation (Tornier, S.A.S.) has one other decision in the tracker over the last 12 months: K260102 (Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System).

Questions & Answers

What did FDA clear under K253674?

K253674 is the FDA 510(k) for Blueprint Patient-Specific Instrumentation, submitted by Stryker Corporation (Tornier, S.A.S.). FDA's decision date was Apr 3, 2026, under product code PHX (Shoulder Prosthesis, Reverse Configuration).

Who makes the Blueprint Patient-Specific Instrumentation?

Stryker Corporation (Tornier, S.A.S.), based in Montbonnot-Saint-Martin, is the applicant of record for K253674.

How long did the K253674 review take?

FDA received the submission on Nov 21, 2025 and issued its decision on Apr 3, 2026, 133 days later.

← All decisions in April 2026

Sources