510(k) Report

FDA applicant

Intellijoint Surgical, Inc.

Waterloo, CA7 decisions2014–20213 recalls

FDA records 7 decisions for Intellijoint Surgical, Inc. (Waterloo, CA) from 2014 to 2021: 7 510(k) clearances. Most are in product codes OLO (Orthopedic Stereotaxic Instrument) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 148 days from receipt to decision, against 91 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 6 of them its own earlier devices. 3 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 Intellijoint Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2014: 12015: 12017: 32019: 12021: 1
2014high 3 (2017) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2026

2019: 12020: 12026 (partial year): 1
2014high 1 (2019) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Intellijoint Surgical, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Intellijoint Surgical, 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 Instrument6decisions
  • LLZSystem, Image Processing, Radiological1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 148 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; 1 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 14 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 6 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.

  • K162364Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc. · 20173cite it
  • K151364Intellijoint HIP (tm) SystemIntellijoint Surgical, Inc. · 20152cite it
  • K191507Intellijoint® Navigation SystemIntellijoint Surgical, Inc. · 20192cite it
  • K133759Intellijoint HipIntellijoint Surgical, Inc. · 20142cite it
  • K172849Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument TrayIntellijoint Surgical, Inc. · 20171cites it
  • K171525Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc. · 20171cites it

What has FDA decided for it lately?

  • K211876Intellijoint VIEWIntellijoint Surgical, Inc. · 2021
  • K191507Intellijoint® Navigation SystemIntellijoint Surgical, Inc. · 20192 recalls
  • K172849Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument TrayIntellijoint Surgical, Inc. · 20171 recall
  • K171525Intellijoint HIP Generation 2B SystemIntellijoint Surgical, Inc. · 2017
  • K162364Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc. · 2017
  • K151364Intellijoint HIP (tm) SystemIntellijoint Surgical, Inc. · 2015
  • K133759Intellijoint HipIntellijoint Surgical, Inc. · 2014

All 7 as Intellijoint Surgical, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K191507Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint…Aug 28, 2026Class II
  • K191507Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product…Feb 11, 2020Class II
  • K172849Workstation, G2, Configured (P/N 000-0241)Jun 28, 2019Class II