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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 / K251840

510(k) cleared

Zimmer® Persona® Personalized Knee System

Zimmer, Inc. · May 28, 2026 · K251840

FDA cleared the Zimmer® Persona® Personalized Knee System from Zimmer, Inc. on May 28, 2026 under K251840, a traditional 510(k). The device falls under product code MBH, Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, regulated at 21 CFR 888.3565 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 16, 2025. The decision came 346 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Zimmer, Inc. has 7 other decisions in the tracker over the last 12 months: K260831 (Z1 Hip System), K261683 (Augment Off-Axis Instrument System), K260182 (Avenir® Müller Stem; Avenir Complete Hip System), K253592 (Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)).

Questions & Answers

What did FDA clear under K251840?

K251840 is the FDA 510(k) for Zimmer® Persona® Personalized Knee System, submitted by Zimmer, Inc.. FDA's decision date was May 28, 2026, under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer).

Who makes the Zimmer® Persona® Personalized Knee System?

Zimmer, Inc., based in Warsaw, IN, is the applicant of record for K251840.

How long did the K251840 review take?

FDA received the submission on Jun 16, 2025 and issued its decision on May 28, 2026, 346 days later.

← All decisions in May 2026