510(k) Report

FDA applicant

Tigon Medical

Millersville, MD7 decisions2019–20260 recalls

FDA records 7 decisions for Tigon Medical (Millersville, MD) from 2019 to 2026: 7 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 118 days from receipt to decision, against 63 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 6 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 Tigon Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2019: 12021: 12023: 12024: 22025: 12026 (partial year): 1
2019high 2 (2024) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

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

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Which product codes does it file in?

  • MBIFastener, Fixation, Nondegradable, Soft Tissue6decisions
  • HWCScrew, Fixation, Bone1decision

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 118 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 63 days; 1 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 13 predicates; 6 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.

  • K182507Tigon Medical Tissue AnchorsTigon Medical · 20192cite it
  • K242529Tigon Medical All-Suture Anchors (ASA)Tigon Medical · 20242cite it
  • K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical · 20251cites it
  • K220464Tigon Medical Gryphon Anchor LineTigon Medical · 20231cites it

What has FDA decided for it lately?

  • K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical · 2026
  • K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical · 2025
  • K242529Tigon Medical All-Suture Anchors (ASA)Tigon Medical · 2024
  • K240175Tigon Medical Fractures, Instability, and Reconstruction (FIRE)Tigon Medical · 2024
  • K220464Tigon Medical Gryphon Anchor LineTigon Medical · 2023
  • K211049Tigon Medical Button SystemTigon Medical · 2021
  • K182507Tigon Medical Tissue AnchorsTigon Medical · 2019

All 7 as Tigon Medical →