510(k) Report

FDA applicant

Spineology, Inc.

Saint Paul, MN54 decisions1999–20250 recalls

FDA records 54 decisions for Spineology, Inc. (Saint Paul, MN) from 1999 to 2025: 53 510(k) clearances and 1 De Novo grant. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 77 days from receipt to decision, against 97 for FDA’s reviews in the same codes and years. Its devices cite 132 predicates, 85 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 Spineology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2009: 12011: 22012: 32013: 52014: 42015: 22016: 62017: 112018: 62019: 32020: 12021: 12022: 12023: 22025: 2
2007high 11 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Spineology, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar22decisions
  • NKBThoracolumbosacral Pedicle Screw System12decisions
  • OLOOrthopedic Stereotaxic Instrument5decisions
  • OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar4decisions
  • OQBIntervertebral Body Graft Containment Device4decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body2decisions

Also: PEK (1), MRW (1), KWP (1), EZX (1), JDK (1).

How long do its 510(k) reviews take?

Since 2016, its 29 510(k)s took a median of 77 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 97 days; 19 of its 29 were faster than that.

Whose devices does it build on?

Its devices cite 132 predicates; 85 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 98 times; 85 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.

  • K111880Spineolgy Peek Bullet Lumber Interbody Fusion DeviceSpineology, Inc. · 20117cite it
  • K113030Spineology Peek Bullet Lumbar Interbody Fusion DeviceSpineology, Inc. · 20126cite it
  • K140010Fortress Pedicle Screw SystemSpineology, Inc. · 20145cite it
  • K143403Threshold Pedicular Fixation SystemSpineology, Inc. · 20145cite it
  • K120293Spineology Peek Lumbar Interbody Fusion DriveSpineology, Inc. · 20125cite it
  • K132053Rampart-O, Rampart-TSpineology, Inc. · 20135cite it

What has FDA decided for it lately?

  • K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc. · 2025
  • K251943Spineology Navigation InstrumentsSpineology, Inc. · 2025
  • K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc. · 2023
  • K231781OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc. · 2023
  • K213876Spineology Navigation InstrumentsSpineology, Inc. · 2022
  • K210155Duo Expandable Interbody Fusion SystemSpineology, Inc. · 2021
  • DEN200010Spineology Interbody Fusion SystemSpineology, Inc. · 2020
  • K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc. · 2019

All 54 as Spineology, Inc. →