510(k) Report

FDA applicant

Orthalign, Inc.

Aliso Viejo, CA15 decisions2009–20262 recalls

FDA records 15 decisions for Orthalign, Inc. (Aliso Viejo, CA) from 2009 to 2026: 15 510(k) clearances. Most are in product codes OLO (Orthopedic Stereotaxic Instrument) and ONN (Intraoperative Orthopedic Joint Assessment Aid). Since 2016 its 510(k)s took a median of 91 days from receipt to decision, against 91 for FDA’s reviews in the same codes and years. Its devices cite 31 predicates, 17 of them its own earlier devices. 2 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, neurology panel, where it files most

How often FDA has decided Orthalign, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2009: 12010: 12011: 12013: 12014: 12016: 12017: 42020: 22024: 12026 (partial year): 2
2009high 4 (2017) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

2in 2026

2026 (partial year): 2
2009high 2 (2026) · low 0 (2009)2026

Class I Class II/III not classified

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

Planning a device like Orthalign, 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?

  • OLOOrthopedic Stereotaxic Instrument12decisions
  • ONNIntraoperative Orthopedic Joint Assessment Aid3decisions

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 91 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 91 days; 4 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 31 predicates; 17 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 25 times; 17 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.

  • K103829Kneealign SystemOrthalign, Inc. · 20114cite it
  • K140331Orthalign Plus SystemOrthalign, Inc. · 20143cite it
  • K172462OrthAlign Plus SystemOrthalign, Inc. · 20173cite it
  • K171780OrthAlign Plus SystemOrthalign, Inc. · 20173cite it
  • K162962OrthAlign Plus SystemOrthalign, Inc. · 20172cite it
  • K130387Orthoalign Plus SystemOrthalign, Inc. · 20132cite it

What has FDA decided for it lately?

  • K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)Orthalign, Inc. · 2026
  • K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeOrthalign, Inc. · 2026
  • K242616Lantern® HipOrthalign, Inc. · 2024
  • K200892Harvey (R) Surgical AssistantOrthalign, Inc. · 20202 recalls
  • K200642OrthAlign Plus SystemOrthalign, Inc. · 2020
  • K172462OrthAlign Plus SystemOrthalign, Inc. · 2017
  • K171780OrthAlign Plus SystemOrthalign, Inc. · 2017
  • K163379KneeAlign 2 SystemOrthalign, Inc. · 2017

All 15 as Orthalign, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K200892Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee…Feb 10, 2026Class II
  • K200892Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern…Feb 10, 2026Class II