510(k) Report

FDA applicant

Genesys Spine

Austin, TX31 decisions2010–20254 recalls

FDA records 31 decisions for Genesys Spine (Austin, TX) from 2010 to 2025: 31 510(k) clearances. 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 89 days from receipt to decision, against 97 for FDA’s reviews in the same codes and years. Its devices cite 124 predicates, 49 of them its own earlier devices. 4 recalls are 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 Genesys Spine’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2010: 22011: 22013: 22014: 22015: 22016: 52017: 32018: 32019: 42020: 12022: 12023: 12024: 12025: 2
2010high 5 (2016) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2015

2011: 12013: 12014: 12015: 1
2010high 1 (2011) · low 0 (2010)2026

Class I Class II/III not classified

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

Planning a device like Genesys Spine’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?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar8decisions
  • NKBThoracolumbosacral Pedicle Screw System6decisions
  • OVEIntervertebral Fusion Device With Integrated Fixation, Cervical6decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body6decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical2decisions
  • OURSacroiliac Joint Fixation2decisions

Also: OLO (1).

How long do its 510(k) reviews take?

Since 2016, its 21 510(k)s took a median of 89 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; 11 of its 21 were faster than that.

Whose devices does it build on?

Its devices cite 124 predicates; 49 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 80 times; 49 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.

  • K103034Genesys Spine Interbody Fusion SystemGenesys Spine · 201022cite it
  • K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine · 20196cite it
  • K100757Tilock Pedicle Screw SystemGenesys Spine · 20105cite it
  • K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine · 20185cite it
  • K103671Genesys Spine Tilock SystemGenesys Spine · 20114cite it
  • K173885Genesys Spine Binary Lumbar Plate SystemGenesys Spine · 20184cite it

What has FDA decided for it lately?

  • K252322SIros-X SystemGenesys Spine · 2025
  • K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine · 2025
  • K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine · 2024
  • K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine · 2023
  • K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine · 2022
  • K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine · 2020
  • K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine · 2019
  • K192678Genesys Spine Binary® Lumbar Plate SystemGenesys Spine · 2019

All 31 as Genesys Spine →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K133245Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical…Nov 5, 2015Class II
  • K100757Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys…Apr 2, 2014Class II
  • K1111323.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical…Feb 20, 2013Class II
  • K103034Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter used in the Genesys Spine…Aug 24, 2011