Cleared Traditional

Signature? ONE System

K232425 · Orthosoft Inc. (d/b/a) Zimmer CAS · Orthopedic

Dec 2023

Decision

123d

Days

Class 2

Risk

About This 510(k) Submission

K232425 is an FDA 510(k) clearance for the Signature? ONE System, a Shoulder Arthroplasty Implantation System (Class II — Special Controls, product code QHE), submitted by Orthosoft Inc. (d/b/a) Zimmer CAS (Montreal, CA). The FDA issued a Cleared decision on December 12, 2023, 123 days after receiving the submission on August 11, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K232425 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 11, 2023
Decision Date	December 12, 2023
Days to Decision	123 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	QHE — Shoulder Arthroplasty Implantation System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660
Definition	Intended To Be Used To Assist In The Implantation Of A Specific Shoulder Arthroplasty Device Or A Set Of Specific Shoulder Arthroplasty Devices. Indicated To Include Guiding Alignment, Making Or Establishing Cuts, Selecting, Sizing, Attaching, Positioning Or Orienting Implant Components.