510(k) Report

FDA applicant

Neo Medical SA

Villette (Lavaux), CH6 decisions2017–20240 recalls

FDA records 6 decisions for Neo Medical SA (Villette (Lavaux), CH) from 2017 to 2024: 6 510(k) clearances. Most are in product codes PML (Bone Cement, Posterior Screw Augmentation) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 134 days from receipt to decision, against 100 for FDA’s reviews in the same codes and years. Its devices cite 24 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 Neo Medical SA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2017: 12019: 22021: 12022: 12024: 1
2017high 2 (2019) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Neo Medical SA by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Neo Medical SA’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?

  • PMLBone Cement, Posterior Screw Augmentation2decisions
  • NKBThoracolumbosacral Pedicle Screw System2decisions
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar2decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 134 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 100 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 24 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA · 20212cite it
  • K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA · 20222cite it
  • K181048Neo Cage System TMNeo Medical SA · 20191cites it

What has FDA decided for it lately?

  • K243693NEO Pedicle Screw System™Neo Medical SA · 2024
  • K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA · 2022
  • K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA · 2021
  • K191796Neo Cage SystemNeo Medical SA · 2019
  • K181048Neo Cage System TMNeo Medical SA · 2019
  • K171582NEO Pedicle Screw System™Neo Medical SA · 2017

All 6 as Neo Medical SA →