# K202716: Ignite Anatomic Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Ignite Orthopedics, LLC
- Decided: May 20, 2021 after 245 days
- Product code: MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K911686 (1991). 159 ancestors in all.
13 later devices descend from it; 5 cite it directly.
1 of 173 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060692: Comprehensive Primary Shoulder Stems, Biomet Manufacturing Corp (2006) Summary page 4.
- K060694: Modular Hybrid Glenoid, Biomet Manufacturing Corp (2006) Summary page 5.
- K060716: Versa-Dial Humeral Head Prosthesis, Biomet Manufacturing Corp (2006) Summary page 5.
- K162024: AltiVate Anatomic Shoulder System, Encore Medical L.P. (2016) Summary page 5.
- K111596: Total Shoulder System, Shoulder Innovations, LLC (2011) Summary page 5.
- K091196: GRS Glenoid Resurfacing System, Arthrosurface, Inc. (2009) Summary page 5.
- K122698: Aequalis Ascend Flex Shoulder System, Tornier S.A.S. (2013) Summary page 5.
- K905786: Global Total Shoulder, Depuy, Inc. (1991) Summary page 5.
- K052472: Depuy Global Shoulder Crosslink Glenoid, DePuy Orthopaedics, Inc. (2005) Summary page 5.
- K121183: Comprehensive Reverse Shoulder - E1 Polyethylene Claims, Biomet Corporation (2012) Summary page 5.

## Most influential descendants
- K212737: INHANCE™ Reverse Shoulder System (2022), 9 descendants of its own
- K203108: Ignite Stemless Anatomic Shoulder System (2021), 3 descendants of its own
- K250644: MSS - Monobloc stem (2026), 1 descendant of its own
- K241817: InSet Total Shoulder System (2025), 1 descendant of its own
- K212933: INHANCETM Hybrid Anatomic Glenoid Implant (2022), 1 descendant of its own

## Indications for use
The Ignite Anatomic Shoulder System is intended for use in total or hemi-shoulder replacement procedures to address the following: * Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. » Rheumatoid arthritis. * Revision where other devices or treatments have failed. * Correction of functional deformity. * Fracture of the humeral head » Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate. Fixation Methods The humeral stem is intended for cemented or cementless use. The glenoid is intended for cemented use only.

Source page: https://510kreport.com/device/K202716
Methodology: https://510kreport.com/methodology