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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 / July 2026 / K253011

510(k) cleared

Catalyft PL Expandable Interbody System

Medtronic Sofamor Danek USA, Inc. · Jul 17, 2026 · K253011

FDA cleared the Catalyft PL Expandable Interbody System from Medtronic Sofamor Danek USA, Inc. on Jul 17, 2026 under K253011, a traditional 510(k). The device falls under product code MAX, Intervertebral Fusion Device With Bone Graft, Lumbar, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 19, 2025. The decision came 301 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medtronic Sofamor Danek USA, Inc. has 7 other decisions in the tracker over the last 12 months: K261020 (Symmetrix L Spinal System), K253656 (OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System), K260216 (CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System), K254165 (Infinity OCT System).

Questions & Answers

What did FDA clear under K253011?

K253011 is the FDA 510(k) for Catalyft PL Expandable Interbody System, submitted by Medtronic Sofamor Danek USA, Inc.. FDA's decision date was Jul 17, 2026, under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

Who makes the Catalyft PL Expandable Interbody System?

Medtronic Sofamor Danek USA, Inc., based in Memphis, TN, is the applicant of record for K253011.

How long did the K253011 review take?

FDA received the submission on Sep 19, 2025 and issued its decision on Jul 17, 2026, 301 days later.

← All decisions in July 2026