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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 / May 2026 / K253966

510(k) cleared

PERLA® TL Posterior Thoraco-lumbar Fixation System

Spineart SA · May 1, 2026 · K253966

FDA cleared the PERLA® TL Posterior Thoraco-lumbar Fixation System from Spineart SA on May 1, 2026 under K253966, a traditional 510(k). The device falls under product code NKB, Thoracolumbosacral Pedicle Screw System, regulated at 21 CFR 888.3070 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 11, 2025. The decision came 141 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Spineart SA has 4 other decisions in the tracker over the last 12 months: K262639 (BAGUERA® C Cervical Disc Surgical Instruments), P250042 (BAGUERA®C Cervical Disc Prosthesis), K261205 (SPINEART Navigation Instrument System), K254158 (SPINEART Navigation Instrument System).

Questions & Answers

What did FDA clear under K253966?

K253966 is the FDA 510(k) for PERLA® TL Posterior Thoraco-lumbar Fixation System, submitted by Spineart SA. FDA's decision date was May 1, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the PERLA® TL Posterior Thoraco-lumbar Fixation System?

Spineart SA, based in Plan-Les-Ouates, is the applicant of record for K253966.

How long did the K253966 review take?

FDA received the submission on Dec 11, 2025 and issued its decision on May 1, 2026, 141 days later.

← All decisions in May 2026

Sources