510(k) Report

FDA applicant

Orthonovis, Inc.

Palm Coast, FL5 decisions2022–20250 recalls

FDA records 5 decisions for Orthonovis, Inc. (Palm Coast, FL) from 2022 to 2025: 5 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 34 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 2 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 Orthonovis, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2022: 12024: 12025: 3
2022high 3 (2025) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Orthonovis, Inc. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Orthonovis, Inc.’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?

  • HRSPlate, Fixation, Bone3decisions
  • HWCScrew, Fixation, Bone1decision
  • KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 34 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; 4 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc. · 20251cites it
  • K242343BPS Wrist Fracture SystemOrthonovis, Inc. · 20241cites it

What has FDA decided for it lately?

  • K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc. · 2025
  • K250498BPS Wrist Fracture SystemOrthonovis, Inc. · 2025
  • K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc. · 2025
  • K242343BPS Wrist Fracture SystemOrthonovis, Inc. · 2024
  • K213905ONX Large External Fixation SystemOrthonovis, Inc. · 2022

All 5 as Orthonovis, Inc. →