510(k) Report

FDA applicant

Spine360

Austin, TX2 decisions2010–20111 recall

FDA records 2 decisions for Spine360 (Austin, TX) from 2010 to 2011: 2 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and MNI (Orthosis, Spinal Pedicle Fixation). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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 Spine360’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2010: 12011: 1
2010high 1 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2017

2017: 1
2010high 1 (2017) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Spine360 by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision
  • MNIOrthosis, Spinal Pedicle Fixation1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K102995Talon Spinal SystemSpine360 · 20113cite it

What has FDA decided for it lately?

  • K102995Talon Spinal SystemSpine360 · 2011
  • K092531SPINE360 Anterior Cervical Plate SystemSpine360 · 20101 recall

All 2 as Spine360 →

What has been recalled?

1 recall linked to its devices; the latest:

  • K092531Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical…Nov 13, 2017Class II