510(k) Report

FDA applicant

Ingenium Spine

Tempe, AZ2 decisions2017–20240 recalls

FDA records 2 decisions for Ingenium Spine (Tempe, AZ) from 2017 to 2024: 2 510(k) clearances. All are in product code NKB (Thoracolumbosacral Pedicle Screw System). Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

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 Ingenium Spine’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2017: 12024: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Ingenium Spine by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NKBThoracolumbosacral Pedicle Screw System2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K173126Arisstos™ Spinal SystemIngenium Spine · 20171cites it

What has FDA decided for it lately?

  • K241258Ingenix Spinal SystemIngenium Spine · 2024
  • K173126Arisstos™ Spinal SystemIngenium Spine · 2017

All 2 as Ingenium Spine →