Cleared Traditional

Smart SPACE Shoulder Planner and 3D Positioners

K222405 · Lima Corporate S.P.A. · Orthopedic

Dec 2022

Decision

133d

Days

Class 2

Risk

About This 510(k) Submission

K222405 is an FDA 510(k) clearance for the Smart SPACE Shoulder Planner and 3D Positioners, a Shoulder Arthroplasty Implantation System (Class II — Special Controls, product code QHE), submitted by Lima Corporate S.P.A. (San Daniele Del Friuli, IT). The FDA issued a Cleared decision on December 20, 2022, 133 days after receiving the submission on August 9, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K222405 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 09, 2022
Decision Date	December 20, 2022
Days to Decision	133 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.