FDA applicant

Medacta Inernational SA

Castel San Pietro (Ch), CH4 decisions2020–20210 recalls

FDA records 4 decisions for Medacta Inernational SA (Castel San Pietro (Ch), CH) from 2020 to 2021: 4 510(k) clearances. Most are in product codes PQC (Pedicle Screw Placement Guide) and MAX (Intervertebral Fusion Device With Bone Graft…). Its devices cite 9 predicates, 0 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 Medacta Inernational SA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2020high 3 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Medacta Inernational SA by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medacta Inernational 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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Other applicant names beginning “Medacta”

FDA records each applicant name separately; these may or may not be the same firm.

Medacta International S.A. 208

Medacta Inernational SA

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Medacta”