510(k) Report

FDA applicant

Surgical Fusion Technologies GmbH

Schlieren, CH2 decisions2024–20260 recalls

FDA records 2 decisions for Surgical Fusion Technologies GmbH (Schlieren, CH) from 2024 to 2026: 2 510(k) clearances. All are in product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue). Its devices cite 4 predicates, 1 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 Surgical Fusion Technologies GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024: 12026 (partial year): 1
2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Surgical Fusion Technologies GmbH by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Surgical Fusion Technologies GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MAIFastener, Fixation, Biodegradable, Soft Tissue2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 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.

  • K240288SF Push- in AnchorSurgical Fusion Technologies GmbH · 20241cites it

What has FDA decided for it lately?

  • K260294SF Push-in AnchorSurgical Fusion Technologies GmbH · 2026
  • K240288SF Push- in AnchorSurgical Fusion Technologies GmbH · 2024

All 2 as Surgical Fusion Technologies GmbH →