# Ignite Orthomotion

- Location (FDA's records): Winona Lake, IN
- FDA decisions: 2 (2024–2025): 2 510(k) clearances
- Product codes: NJD (2)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mako Surgical Corp.: 1 (https://510kreport.com/company/mako-surgical)

## Its most-cited devices
- K242307: ACHIEVE Partial Knee System (2024), cited by 1

## Recent decisions
- K251975: Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component (Sep 2, 2025)
- K242307: ACHIEVE Partial Knee System (Dec 16, 2024)

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