# Ignite Orthopedics, LLC

- Location (FDA's records): Winona Lake, IN
- FDA decisions: 3 (2019–2021): 3 510(k) clearances
- Names in FDA's records: Ignite Orthopedics, LLC (2); Ignite Orthopedics, Inc. (1)
- Product codes: KWI (1), MBF (1), PKC (1)
- Predicates its devices cite: 19 (1 its own); citations of its devices by later devices: 10 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biomet Manufacturing Corp: 4 (https://510kreport.com/company/biomet-manufacturing)
- Encore Medical L.P.: 2 (https://510kreport.com/company/encore-medical)
- Tornier, Inc.: 2 (https://510kreport.com/company/tornier)
- Wrightmedicaltechnologyinc: 1 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Shoulder Innovations, Inc.: 1 (https://510kreport.com/company/shoulder-innovations)
- Arthrosurface, Inc.: 1 (https://510kreport.com/company/arthrosurface)
- Depuy, Inc.: 1 (https://510kreport.com/company/depuy)
- DePuy Orthopaedics, Inc.: 1 (https://510kreport.com/company/depuy-orthopaedics)

## Firms that cite its devices most
- Depuy Ireland UC: 7 (https://510kreport.com/company/depuy-ireland-uc)
- BioPoly, LLC: 1 (https://510kreport.com/company/biopoly)
- DePuy Synthes: 1 (https://510kreport.com/company/depuy-synthes)

## Its most-cited devices
- K202716: Ignite Anatomic Shoulder System (2021), cited by 5
- K203108: Ignite Stemless Anatomic Shoulder System (2021), cited by 3
- K183618: Revolution Radial Head (2019), cited by 2

## Recent decisions
- K203108: Ignite Stemless Anatomic Shoulder System (Jul 16, 2021)
- K202716: Ignite Anatomic Shoulder System (May 20, 2021)
- K183618: Revolution Radial Head (May 17, 2019)

Source page: https://510kreport.com/company/ignite-orthopedics