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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 / K254084

510(k) cleared

AETOS Shoulder System - CONCELOC Glenoids

Smith & Nephew, Inc. · Apr 6, 2026 · K254084

FDA cleared the AETOS Shoulder System - CONCELOC Glenoids from Smith & Nephew, Inc. on Apr 6, 2026 under K254084, 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 Dec 18, 2025. The decision came 109 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Smith & Nephew, Inc. has 6 other decisions in the tracker over the last 12 months: K261968 (Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)), DEN250037 (TESSA Spatial Surgery System; INTELLIO Tablet (72205455)), K260646 (RENASYS EDGE (66803126)), K252416 (AETOS Shoulder System Meta Humeral Prosthesis Size 0).

Questions & Answers

What did FDA clear under K254084?

K254084 is the FDA 510(k) for AETOS Shoulder System - CONCELOC Glenoids, submitted by Smith & Nephew, Inc.. FDA's decision date was Apr 6, 2026, under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented).

Who makes the AETOS Shoulder System - CONCELOC Glenoids?

Smith & Nephew, Inc., based in Cordova, TN, is the applicant of record for K254084.

How long did the K254084 review take?

FDA received the submission on Dec 18, 2025 and issued its decision on Apr 6, 2026, 109 days later.

← All decisions in April 2026