Cleared Traditional

Freedom Metaphyseal Cone Implants (Metaphyseal Cones)

K252777 · Maxx Orthopedics, Inc. · Orthopedic

Oct 2025

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K252777 is an FDA 510(k) clearance for the Freedom Metaphyseal Cone Implants (Metaphyseal Cones), a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II — Special Controls, product code MBH), submitted by Maxx Orthopedics, Inc. (Norristown, US). The FDA issued a Cleared decision on October 31, 2025, 59 days after receiving the submission on September 2, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K252777 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 02, 2025
Decision Date	October 31, 2025
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MBH — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3565