510(k) Report

FDA applicant

Tarsus Medical, Inc.

Mountain View, CA2 decisions2011–20120 recalls

FDA records 2 decisions for Tarsus Medical, Inc. (Mountain View, CA) from 2011 to 2012: 2 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and HWC (Screw, Fixation, Bone). Its devices cite 2 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 Tarsus Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2011: 12012: 1
2011high 1 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Tarsus Medical, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tarsus Medical, Inc.’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?

  • MBIFastener, Fixation, Nondegradable, Soft Tissue1decision
  • HWCScrew, Fixation, Bone1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K111971Synde-Lock Syndesmosis Repair KitTarsus Medical, Inc. · 2012
  • K110800Meta-Lock Suture Anchor SystemTarsus Medical, Inc. · 2011

All 2 as Tarsus Medical, Inc. →