510(k) Report

FDA applicant

Spinecraft, LLC

Westmont, IL18 decisions2006–20261 recall

FDA records 18 decisions for Spinecraft, LLC (Westmont, IL) from 2006 to 2026: 18 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and ODP (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 59 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 127 predicates, 26 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “SpineCraft”, “Spinecraft, 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 Spinecraft, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2009: 12010: 22011: 22013: 22015: 22018: 12021: 22022: 12023: 12026 (partial year): 2
2007high 2 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Spinecraft, 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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Which product codes does it file in?

  • NKBThoracolumbosacral Pedicle Screw System6decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical3decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body3decisions
  • KWPAppliance, Fixation, Spinal Interlaminal2decisions
  • MNHOrthosis, Spondylolisthesis Spinal Fixation1decision
  • NKGPosterior Cervical Screw System1decision

Also: OLO (1), MQV (1).

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 59 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 88 days; 5 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 127 predicates; 26 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 44 times; 26 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.

  • K062513Apex Spine SystemSpinecraft, Inc. · 20068cite it
  • K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC · 20107cite it
  • K092825Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherSpinecraft, Inc. · 20107cite it
  • K090887Orio-C Cervical, Orio-TL Tlif, Orio-PL Plif, Orio-AL Alif Intervedrtebral Body Fusion CagesSpineCraft · 20095cite it
  • K150417Astra Spine SystemSpinecraft, LLC · 20154cite it
  • K110906Apex Spine SystemSpinecraft, LLC · 20113cite it

What has FDA decided for it lately?

  • K253260ORIO-3D Cage SystemSpineCraft · 2026
  • K260015ANTERIS Thoracolumbar Plate SystemSpineCraft · 2026
  • K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC · 2023
  • K223273ASTRA Spine SystemSpinecraft, LLC · 2022
  • K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC · 2021
  • K211323ASTRA Spine SystemSpinecraft, LLC · 2021
  • K181350ASTRA-OCT Spine SystemSpinecraft, LLC · 2018
  • K143683APEX-DL Spine SystemSpinecraft, LLC · 2015

All 12 as Spinecraft, LLC →All 3 as SpineCraft →All 3 as Spinecraft, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K060226ARTISTE and ONCOR linear accelerators with G31 mother board. ARTISTE and ONCOR are…Nov 9, 2011