510(k) Report

FDA applicant

Osartis GmbH

Münster, DE6 decisions2019–20240 recalls

FDA records 6 decisions for Osartis GmbH (Münster, DE) from 2019 to 2024: 6 510(k) clearances. Most are in product codes LOD (Bone Cement) and MBB (Bone Cement, Antibiotic). Since 2016 its 510(k)s took a median of 89 days from receipt to decision, against 95 for FDA’s reviews in the same codes and years. Its devices cite 15 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 Osartis GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2019: 22021: 32024: 1
2019high 3 (2021) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Osartis GmbH by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Osartis GmbH’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?

  • LODBone Cement5decisions
  • MBBBone Cement, Antibiotic1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 89 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 95 days; 3 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 15 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH · 20211cites it

What has FDA decided for it lately?

  • K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH · 2024
  • K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH · 2021
  • K210125BonOs HV Genta, BonOs MV Genta, BonOs LV GentaOsartis GmbH · 2021
  • K210120BonOs HV, BonOs MV, BonOs LVOsartis GmbH · 2021
  • K192394Hi-Fatigue Bone CementOsartis GmbH · 2019
  • K192379Hi-Fatigue G Bone CementOsartis GmbH · 2019

All 6 as Osartis GmbH →