Cleared Traditional

MOTO Partial Knee System Extension

K251618 · Medacta International S.A. · Orthopedic

Jul 2025

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K251618 is an FDA 510(k) clearance for the MOTO Partial Knee System Extension, a Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HSX), submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on July 24, 2025, 58 days after receiving the submission on May 27, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3520.

Submission Details

510(k) Number	K251618 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 2025
Decision Date	July 24, 2025
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HSX — Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3520