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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
510(k) Number K203108
Device Name Ignite Stemless Anatomic Shoulder System
Applicant
Ignite Orthopedics, LLC
700 Park Ave.
Suite F
Winona Lake,  IN  46590
Applicant Contact Matt Purdy
Correspondent
Ignite Orthopedics, LLC
700 Park Ave.
Suite F
Winona Lake,  IN  46590
Correspondent Contact Russ Parott
Regulation Number888.3660
Classification Product Code
PKC  
Subsequent Product Code
PAO  
Date Received10/15/2020
Decision Date 07/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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