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 / February 2026 / K252597

510(k) cleared

Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)

Alphatec Spine, Inc. · Feb 19, 2026 · K252597

FDA cleared the Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) from Alphatec Spine, Inc. on Feb 19, 2026 under K252597, a traditional 510(k). The device falls under product code OLO, Orthopedic Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Aug 15, 2025. The decision came 188 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), K253615 (Invictus Bands System), K252842 (SafeOp 3: Neural Informatix System).

Questions & Answers

What did FDA clear under K252597?

K252597 is the FDA 510(k) for Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation), submitted by Alphatec Spine, Inc.. FDA's decision date was Feb 19, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)?

Alphatec Spine, Inc., based in Carlsbad, CA, is the applicant of record for K252597.

How long did the K252597 review take?

FDA received the submission on Aug 15, 2025 and issued its decision on Feb 19, 2026, 188 days later.

← All decisions in February 2026

Sources