PeriPRO Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System— 510(k) K222381

Name: FDA 510(k) clearance K222381
Creator: U.S. Food and Drug Administration
Published: 2023-04-27

Substantially Equivalent

Stryker GmbH

FDA 510(k) clearance K222381 for PeriPRO Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System, Substantially Equivalent on 2023-04-27. Applicant: Stryker GmbH. Device class: 2.

Clearance details

Applicant: Stryker GmbH
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2022-08-05
Decision date: 2023-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

Download summary PDF View on FDA.gov ↗

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K253202 — Hoffmann LRF System2025-12-19
K251400 — T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System2025-08-20
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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.