Cleared Traditional

AltiVate Anatomic Canal-Sparing (CS) Shoulder

K193226 · Encore Medical, L.P. · Orthopedic

Jun 2020

Decision

194d

Days

Class 2

Risk

About This 510(k) Submission

K193226 is an FDA 510(k) clearance for the AltiVate Anatomic Canal-Sparing (CS) Shoulder, a Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained (Class II — Special Controls, product code PKC), submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on June 3, 2020, 194 days after receiving the submission on November 22, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K193226 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 22, 2019
Decision Date	June 03, 2020
Days to Decision	194 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PKC — Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660
Definition	Replacement Of The Humeral Head For Total Anatomic Shoulder Arthroplasty