WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K253260

510(k) cleared

ORIO-3D Cage System

SpineCraft · Apr 16, 2026 · K253260

FDA cleared the ORIO-3D Cage System from SpineCraft on Apr 16, 2026 under K253260, a traditional 510(k). The device falls under product code ODP, Intervertebral Fusion Device With Bone Graft, Cervical, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 29, 2025. The decision came 199 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

SpineCraft has one other decision in the tracker over the last 12 months: K260015 (ANTERIS Thoracolumbar Plate System).

Questions & Answers

What did FDA clear under K253260?

K253260 is the FDA 510(k) for ORIO-3D Cage System, submitted by SpineCraft. FDA's decision date was Apr 16, 2026, under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

Who makes the ORIO-3D Cage System?

SpineCraft, based in Westmont, IL, is the applicant of record for K253260.

How long did the K253260 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Apr 16, 2026, 199 days later.

← All decisions in April 2026

Sources