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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 / March 2026 / K253615

510(k) cleared

Invictus Bands System

Alphatec Spine, Inc. · Mar 25, 2026 · K253615

FDA cleared the Invictus Bands System from Alphatec Spine, Inc. on Mar 25, 2026 under K253615, a traditional 510(k). The device falls under product code OWI, Bone Fixation Cerclage, Sublaminar, regulated at 21 CFR 888.3010 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Nov 18, 2025. The decision came 127 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Alphatec Spine, Inc. has 4 other decisions in the tracker over the last 12 months: K261284 (Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System), K253216 (IntraOp Alignment System; CONTOUR3D Bending System), K252597 (Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)), K252842 (SafeOp 3: Neural Informatix System).

Questions & Answers

What did FDA clear under K253615?

K253615 is the FDA 510(k) for Invictus Bands System, submitted by Alphatec Spine, Inc.. FDA's decision date was Mar 25, 2026, under product code OWI (Bone Fixation Cerclage, Sublaminar).

Who makes the Invictus Bands System?

Alphatec Spine, Inc., based in Carlsbad, CA, is the applicant of record for K253615.

How long did the K253615 review take?

FDA received the submission on Nov 18, 2025 and issued its decision on Mar 25, 2026, 127 days later.

← All decisions in March 2026