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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 / August 2026 / K254043

510(k) cleared

TRIVANCE Hip Stem

Globus Medical, Inc. · Aug 4, 2026 · K254043

FDA cleared the TRIVANCE Hip Stem from Globus Medical, Inc. on Aug 4, 2026 under K254043, a traditional 510(k). The device falls under product code LPH, Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, regulated at 21 CFR 888.3358 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 17, 2025. The decision came 230 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Globus Medical, Inc. has 7 other decisions in the tracker over the last 12 months: K262251 (ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)), K253739 (SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System), K253401 (SCRIPT Implant System), K261043 (AUTOBAHN Nailing System).

Questions & Answers

What did FDA clear under K254043?

K254043 is the FDA 510(k) for TRIVANCE Hip Stem, submitted by Globus Medical, Inc.. FDA's decision date was Aug 4, 2026, under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented).

Who makes the TRIVANCE Hip Stem?

Globus Medical, Inc., based in Audubon, PA, is the applicant of record for K254043.

How long did the K254043 review take?

FDA received the submission on Dec 17, 2025 and issued its decision on Aug 4, 2026, 230 days later.

← All decisions in August 2026