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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 / October 2025 / K252777

510(k) cleared

Freedom Metaphyseal Cone Implants (Metaphyseal Cones)

Maxx Orthopedics, Inc. · Oct 31, 2025 · K252777

FDA cleared the Freedom Metaphyseal Cone Implants (Metaphyseal Cones) from Maxx Orthopedics, Inc. on Oct 31, 2025 under K252777, 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 2, 2025. The decision came 59 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)), K253314 (Freedom Infinia Total Knee System), K253144 (Freedom® Total Knee System Titan PCK Components).

Questions & Answers

What did FDA clear under K252777?

K252777 is the FDA 510(k) for Freedom Metaphyseal Cone Implants (Metaphyseal Cones), submitted by Maxx Orthopedics, Inc.. FDA's decision date was Oct 31, 2025, under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer).

Who makes the Freedom Metaphyseal Cone Implants (Metaphyseal Cones)?

Maxx Orthopedics, Inc., based in Norristown, PA, is the applicant of record for K252777.

How long did the K252777 review take?

FDA received the submission on Sep 2, 2025 and issued its decision on Oct 31, 2025, 59 days later.

← All decisions in October 2025

Sources