# K203108: Ignite Stemless Anatomic Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Ignite Orthopedics, LLC
- Decided: Jul 16, 2021 after 274 days
- Product code: PKC (Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K911686 (1991). 178 ancestors in all.
3 later devices descend from it; 3 cite it directly.
1 of 182 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171858: Sidus Stem-Free Shoulder, Zimmer GmbH (2017) Summary page 4.
- K202716: Ignite Anatomic Shoulder System, Ignite Orthopedics, LLC (2021). Cleared while this submission was under review Summary page 4.
- K143552: Simpliciti Shoulder System, Tornier, Inc. (2015) Summary page 4.
- K182516: Comprehensive Nano Stemless Shoulder, Biomet Manufacturing Corp (2019) Summary page 4.
- K183194: Arthrex Eclipse Shoulder Prosthesis System, Arthrex, Inc. (2019) Summary page 4.
- K173388: Exactech Equinoxe Stemless Shoulder, Exactech, Inc. (2018) Summary page 4.
- K193226: AltiVate Anatomic Canal-Sparing (CS) Shoulder, Encore Medical L.P. (2020) Summary page 4.
- K083439: Synthes Epoca Shoulder Prosthesis System, Synthes (Usa) (2009) Summary page 4.

## Most influential descendants
- K243248: Inhance Intact™ (2024), 0 descendants of its own
- K230831: INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid (2023), 0 descendants of its own
- K223211: INHANCETM Shoulder System – Humeral Stems and Stemless (2022), 0 descendants of its own

## Indications for use
The Ignite Stemless Anatomic Shoulder Prosthesis is intended for use in total shoulder replacement procedures to address the following: * Osteoarthritis; » Posttraumatic arthrosis; » Focal avascular necrosis of the humeral head; * Previous surgeries of the shoulder that do not compromise the fixation. Fixation Methods The stemless anchor is intended for cementless use. The glenoid is intended for cemented use only.

Source page: https://510kreport.com/device/K203108
Methodology: https://510kreport.com/methodology