WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / October 2025 / K253314

510(k) cleared

Freedom Infinia Total Knee System

Maxx Orthopedics, Inc. · Oct 29, 2025 · K253314

FDA cleared the Freedom Infinia Total Knee System from Maxx Orthopedics, Inc. on Oct 29, 2025 under K253314, a special 510(k). The device falls under product code JWH, Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, regulated at 21 CFR 888.3560 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 30, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Maxx Orthopedics, Inc. has 4 other decisions in the tracker over the last 12 months: K261563 (Freedom Total Knee System (E-Poly Tibial Liners)), K253171 (Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)), K252777 (Freedom Metaphyseal Cone Implants (Metaphyseal Cones)), K253144 (Freedom® Total Knee System Titan PCK Components).

Questions & Answers

What did FDA clear under K253314?

K253314 is the FDA 510(k) for Freedom Infinia Total Knee System, submitted by Maxx Orthopedics, Inc.. FDA's decision date was Oct 29, 2025, under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer).

Who makes the Freedom Infinia Total Knee System?

Maxx Orthopedics, Inc., based in Norristown, PA, is the applicant of record for K253314.

How long did the K253314 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Oct 29, 2025, 29 days later.

← All decisions in October 2025

Sources