Cleared Traditional

Balanced Knee System TriMax Porous Femoral Components

K253161 · Ortho Development Corp. · Orthopedic

Dec 2025

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K253161 is an FDA 510(k) clearance for the Balanced Knee System TriMax Porous Femoral Components, a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II — Special Controls, product code MBH), submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on December 19, 2025, 84 days after receiving the submission on September 26, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K253161 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2025
Decision Date	December 19, 2025
Days to Decision	84 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