510(k) Report

FDA applicant

Spineway

Ecully, FR7 decisions2015–20230 recalls

FDA records 7 decisions for Spineway (Ecully, FR) from 2015 to 2023: 7 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 92 days from receipt to decision, against 84 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Spineway SA”.

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

FDA decisions per year

1in 2023

2015: 32016: 12017: 12019: 12023: 1
2015high 3 (2015) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Spineway by year, 2015–2026Sources: 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 System4decisions
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision
  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 92 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 84 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 18 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 3 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.

  • K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA · 20163cite it
  • K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway · 20151cites it
  • K150185Mont Blanc Spinal SystemSpineway · 20151cites it
  • K150036Blue Mountain Cervical Plate SystemSpineway · 20151cites it

What has FDA decided for it lately?

  • K231658VEOS Spinal Fixation SystemSpineway · 2023
  • K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA · 2019
  • K162694Ayers Rock Cervical interbody fusion systemSpineway · 2017
  • K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA · 2016
  • K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway · 2015
  • K150185Mont Blanc Spinal SystemSpineway · 2015
  • K150036Blue Mountain Cervical Plate SystemSpineway · 2015

All 5 as Spineway →All 2 as Spineway SA →