Paragon 28 APEX 3D Total Ankle Replacement System— 510(k) K192994

Name: FDA 510(k) clearance K192994
Creator: U.S. Food and Drug Administration
Published: 2020-07-10

Substantially Equivalent

Paragon 28, Inc.

FDA 510(k) clearance K192994 for Paragon 28 APEX 3D Total Ankle Replacement System, Substantially Equivalent on 2020-07-10. Applicant: Paragon 28, Inc.. Device class: 2.

Clearance details

Applicant: Paragon 28, Inc.
Product code: Code HSN
Device class: Class 2
Regulation: 21 CFR 888.3110
Advisory panel: Orthopedic
Date received: 2019-10-25
Decision date: 2020-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HSN

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K253159 — Prophecy Incompass Surgical Planning System2026-06-16
K252454 — Kinos Total Ankle System2025-09-03
K250037 — Incompass Total Ankle System2025-06-20
K250641 — APEX 3D Total Ankle Replacement System2025-05-01
K240475 — Hintermann Series H2 Total Ankle System2024-12-02

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Adverse events under product code HSN

product code HSN

Death: 3
Injury: 4,711
Total: 4,714

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.