510(k) Report

FDA applicant

Next Orthosurgical

Vista, CA6 decisions2013–20240 recalls

FDA records 6 decisions for Next Orthosurgical (Vista, CA) from 2013 to 2024: 6 510(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 85 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 27 predicates, 3 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 Next Orthosurgical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2013: 12014: 12016: 22020: 12024: 1
2013high 2 (2016) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Next Orthosurgical by year, 2013–2026Sources: 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 System3decisions
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar2decisions
  • 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 85 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; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 27 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.

  • K131082Interform Interbody Cage SystemNext Orthosurgical · 20133cite it
  • K141291Vertiform Posterior Fixation SystemNext Orthosurgical · 20142cite it
  • K161499VertiForm Posterior Fixation SystemNext Orthosurgical · 20161cites it

What has FDA decided for it lately?

  • K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical · 2024
  • K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical · 2020
  • K161608InterForm Cervical Interbody Cage SystemNext Orthosurgical · 2016
  • K161499VertiForm Posterior Fixation SystemNext Orthosurgical · 2016
  • K141291Vertiform Posterior Fixation SystemNext Orthosurgical · 2014
  • K131082Interform Interbody Cage SystemNext Orthosurgical · 2013

All 6 as Next Orthosurgical →

Other applicant names beginning “Next”

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

Next Science, LLC 6Next Mobility, LLC 2Next Wave, Inc. 2Next Millennium Software Solutions, Inc. 1Next Sight Srl 1