510(k) Report

FDA applicant

Nexxt Spine, LLC

Noblesville, IN24 decisions2009–20250 recalls

FDA records 24 decisions for Nexxt Spine, LLC (Noblesville, IN) from 2009 to 2025: 24 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Since 2016 its 510(k)s took a median of 53 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 90 predicates, 33 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Nexxt Spine”.

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 Nexxt Spine, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2009: 12010: 12012: 12013: 32014: 12016: 12017: 12018: 12019: 22020: 72022: 22023: 12024: 12025: 1
2009high 7 (2020) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Nexxt Spine, LLC by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nexxt Spine, 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?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar4decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body3decisions
  • NKBThoracolumbosacral Pedicle Screw System3decisions
  • OVEIntervertebral Fusion Device With Integrated Fixation, Cervical2decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical2decisions
  • MNHOrthosis, Spondylolisthesis Spinal Fixation2decisions

Also: MNI (2), OLO (1), NKG (1), OUR (1), PLR (1), MRW (1).

How long do its 510(k) reviews take?

Since 2016, its 16 510(k)s took a median of 53 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 11 of its 16 were faster than that.

Whose devices does it build on?

Its devices cite 90 predicates; 33 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 71 times; 33 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.

  • K171140Matrixx SystemNexxt Spine, LLC · 201714cite it
  • K120345Honour Spacer SystemNexxt Spine, LLC · 20129cite it
  • K101278Inertia Pedicle Screw SystemNexxt Spine, LLC · 20107cite it
  • K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC · 20205cite it
  • K090984Inertia Pedicle Screw SystemNexxt Spine, LLC · 20095cite it
  • K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC · 20164cite it

What has FDA decided for it lately?

  • K243838NEXXT MATRIXX® SI SystemNexxt Spine · 2025
  • K240690STRUXXURE® MCS Anterior Cervical Plate SystemNexxt Spine · 2024
  • K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC · 2023
  • K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC · 2022
  • K220291NEXXT SPINE NAVIGATION SystemNexxt Spine, LLC · 2022
  • K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC · 2020
  • K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC · 2020
  • K200969NEXXT MATRIXX SystemNexxt Spine, LLC · 2020

All 22 as Nexxt Spine, LLC →All 2 as Nexxt Spine →

Other applicant names beginning “Nexxt”

FDA records each applicant name separately; these may or may not be the same firm.

Nexxt Medical, Inc. 1