510(k) Report

FDA applicant

Spineworks, LLC

Round Rock, TX4 decisions2005–20140 recalls

FDA records 4 decisions for Spineworks, LLC (Round Rock, TX) from 2005 to 2014: 4 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and MQP (Spinal Vertebral Body Replacement Device). Its devices cite 10 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 Spineworks, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2008: 12011: 12014: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Spineworks, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar2decisions
  • MQPSpinal Vertebral Body Replacement Device1decision
  • MNHOrthosis, Spondylolisthesis Spinal Fixation1decision

Whose devices does it build on?

Its devices cite 10 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 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.

  • K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC · 20113cite it
  • K081331Fixxsure Cross LinkSpineworks, LLC · 20082cite it
  • K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC · 20141cites it

What has FDA decided for it lately?

  • K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC · 2014
  • K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC · 2011
  • K081331Fixxsure Cross LinkSpineworks, LLC · 2008
  • K042600Stansion MatrixSpineworks, LLC · 2005

All 4 as Spineworks, LLC →