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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 / DEN250037

510(k) cleared

TESSA Spatial Surgery System; INTELLIO Tablet (72205455)

Smith & Nephew, Inc. · Jul 6, 2026 · DEN250037

FDA cleared the TESSA Spatial Surgery System; INTELLIO Tablet (72205455) from Smith & Nephew, Inc. on Jul 6, 2026 under DEN250037, a direct 510(k). The device falls under product code SIQ, Intra-Articular Orthopedic Stereotaxic Navigation Instrument, regulated at 21 CFR 888.4561 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 22, 2025. The decision came 318 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Smith & Nephew, Inc. has 6 other decisions in the tracker over the last 12 months: K261968 (Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)), K260646 (RENASYS EDGE (66803126)), K254084 (AETOS Shoulder System - CONCELOC Glenoids), K252416 (AETOS Shoulder System Meta Humeral Prosthesis Size 0).

Questions & Answers

What did FDA clear under DEN250037?

DEN250037 is the FDA 510(k) for TESSA Spatial Surgery System; INTELLIO Tablet (72205455), submitted by Smith & Nephew, Inc.. FDA's decision date was Jul 6, 2026, under product code SIQ (Intra-Articular Orthopedic Stereotaxic Navigation Instrument).

Who makes the TESSA Spatial Surgery System; INTELLIO Tablet (72205455)?

Smith & Nephew, Inc., based in Andover, MA, is the applicant of record for DEN250037.

How long did the DEN250037 review take?

FDA received the submission on Aug 22, 2025 and issued its decision on Jul 6, 2026, 318 days later.

← All decisions in July 2026