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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 / K252129

510(k) cleared

AETOS Shoulder System Stemless Humeral Prosthesis

Smith & Nephew, Inc. · Oct 3, 2025 · K252129

FDA cleared the AETOS Shoulder System Stemless Humeral Prosthesis from Smith & Nephew, Inc. on Oct 3, 2025 under K252129, a traditional 510(k). The device falls under product code PKC, Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained, regulated at 21 CFR 888.3660 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jul 7, 2025. The decision came 88 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 K252129?

K252129 is the FDA 510(k) for AETOS Shoulder System Stemless Humeral Prosthesis, submitted by Smith & Nephew, Inc.. FDA's decision date was Oct 3, 2025, under product code PKC (Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained).

Who makes the AETOS Shoulder System Stemless Humeral Prosthesis?

Smith & Nephew, Inc., based in Cordova, TX, is the applicant of record for K252129.

How long did the K252129 review take?

FDA received the submission on Jul 7, 2025 and issued its decision on Oct 3, 2025, 88 days later.

← All decisions in October 2025