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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 / March 2026 / K253189

510(k) cleared

Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)

Zimmer, Inc. · Mar 9, 2026 · K253189

FDA cleared the Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) from Zimmer, Inc. on Mar 9, 2026 under K253189, 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 Sep 26, 2025. The decision came 164 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), K251840 (Zimmer® Persona® Personalized Knee System), K260182 (Avenir® Müller Stem; Avenir Complete Hip System).

Questions & Answers

What did FDA clear under K253189?

K253189 is the FDA 510(k) for Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs), submitted by Zimmer, Inc.. FDA's decision date was Mar 9, 2026, under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer).

Who makes the Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)?

Zimmer, Inc., based in Warsaw, IN, is the applicant of record for K253189.

How long did the K253189 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Mar 9, 2026, 164 days later.

← All decisions in March 2026