FDA applicant

Ignite Orthopedics, LLC

Winona Lake, IN3 decisions2019–20211 recall

FDA records 3 decisions for Ignite Orthopedics, LLC (Winona Lake, IN) from 2019 to 2021: 3 510(k) clearances. Most are in product codes KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer) and MBF (Prosthesis, Shoulder, Semi-Constrained…). Its devices cite 19 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Ignite Orthopedics, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Ignite Orthopedics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2021

2019high 2 (2021) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

1in 2022

2019high 1 (2022) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Ignite Orthopedics, LLC by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ignite Orthopedics, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Ignite”

FDA records each applicant name separately; these may or may not be the same firm.

Ignite Orthomotion 2

Ignite Orthopedics, LLC

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Ignite”