510(k) Report

FDA applicant

Novastep

Saint Gregoire, FR9 decisions2015–20260 recalls

FDA records 9 decisions for Novastep (Saint Gregoire, FR) from 2015 to 2026: 9 510(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 185 days from receipt to decision, against 86 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Novastep SAS”.

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 Novastep’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2015: 52019: 12023: 22026 (partial year): 1
2015high 5 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Novastep by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Novastep’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, Bone4decisions
  • HWCScrew, Fixation, Bone3decisions
  • HTYPin, Fixation, Smooth1decision
  • JDRStaple, Fixation, Bone1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 185 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 86 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 18 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 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.

  • K143229Nexis osteosynthesis compressive screwsNovastep · 20153cite it
  • K143523Airlock osteosynthesis plate systemNovastep · 20152cite it
  • K143146Nexis osteosynthesis snap-off screwsNovastep · 20151cites it
  • K192356Airlock Centrolock Osteosynthesis Implant SystemNovastep · 20191cites it
  • K151277Airlock® osteosynthesis plate systemNovastep · 20151cites it

What has FDA decided for it lately?

  • K260274Airlock® Ankle Plating SystemNovastep SAS · 2026
  • K230724arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesNovastep · 2023
  • K223468Nexis® compressive screwsNovastep · 2023
  • K192356Airlock Centrolock Osteosynthesis Implant SystemNovastep · 2019
  • K151277Airlock® osteosynthesis plate systemNovastep · 2015
  • K143523Airlock osteosynthesis plate systemNovastep · 2015
  • K143049LYNC intramedullary implantNovastep · 2015
  • K143146Nexis osteosynthesis snap-off screwsNovastep · 2015

All 8 as Novastep →The one decision as Novastep SAS →