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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 / K252416

510(k) cleared

AETOS Shoulder System Meta Humeral Prosthesis Size 0

Smith & Nephew, Inc. · Oct 29, 2025 · K252416

FDA cleared the AETOS Shoulder System Meta Humeral Prosthesis Size 0 from Smith & Nephew, Inc. on Oct 29, 2025 under K252416, 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 Aug 1, 2025. The decision came 89 days later, inside the 90 FDA-day goal for a 510(k).

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)), K254084 (AETOS Shoulder System - CONCELOC Glenoids).

Questions & Answers

What did FDA clear under K252416?

K252416 is the FDA 510(k) for AETOS Shoulder System Meta Humeral Prosthesis Size 0, submitted by Smith & Nephew, Inc.. FDA's decision date was Oct 29, 2025, under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented).

Who makes the AETOS Shoulder System Meta Humeral Prosthesis Size 0?

Smith & Nephew, Inc., based in Cordova, TN, is the applicant of record for K252416.

How long did the K252416 review take?

FDA received the submission on Aug 1, 2025 and issued its decision on Oct 29, 2025, 89 days later.

← All decisions in October 2025