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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 / January 2026 / K254003

510(k) cleared

JARVIS Metaphyseal Stem

FH Industrie · Jan 9, 2026 · K254003

FDA cleared the JARVIS Metaphyseal Stem from FH Industrie on Jan 9, 2026 under K254003, a special 510(k). The device falls under product code PHX, Shoulder Prosthesis, Reverse Configuration, regulated at 21 CFR 888.3660 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 15, 2025. The decision came 25 days later, inside the 90 FDA-day goal for a 510(k).

FH Industrie has one other decision in the tracker over the last 12 months: K253345 (JARVIS Diaphyseal Stem Standard).

Questions & Answers

What did FDA clear under K254003?

K254003 is the FDA 510(k) for JARVIS Metaphyseal Stem, submitted by FH Industrie. FDA's decision date was Jan 9, 2026, under product code PHX (Shoulder Prosthesis, Reverse Configuration).

Who makes the JARVIS Metaphyseal Stem?

FH Industrie, based in Quimper Finistere, is the applicant of record for K254003.

How long did the K254003 review take?

FDA received the submission on Dec 15, 2025 and issued its decision on Jan 9, 2026, 25 days later.

← All decisions in January 2026

Sources