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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 / December 2025 / K253161

510(k) cleared

Balanced Knee System TriMax Porous Femoral Components

Ortho Development Corp. · Dec 19, 2025 · K253161

FDA cleared the Balanced Knee System TriMax Porous Femoral Components from Ortho Development Corp. on Dec 19, 2025 under K253161, 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 84 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Ortho Development Corp. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253161?

K253161 is the FDA 510(k) for Balanced Knee System TriMax Porous Femoral Components, submitted by Ortho Development Corp.. FDA's decision date was Dec 19, 2025, under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer).

Who makes the Balanced Knee System TriMax Porous Femoral Components?

Ortho Development Corp., based in Draper, UT, is the applicant of record for K253161.

How long did the K253161 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Dec 19, 2025, 84 days later.

← All decisions in December 2025