Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System— 510(k) K213199

Name: FDA 510(k) clearance K213199
Creator: U.S. Food and Drug Administration
Published: 2022-01-11

Substantially Equivalent

Stryker GmbH

FDA 510(k) clearance K213199 for Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System, Substantially Equivalent on 2022-01-11. Applicant: Stryker GmbH. Device class: 2.

Clearance details

Applicant: Stryker GmbH
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2021-09-29
Decision date: 2022-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

Download summary PDF View on FDA.gov ↗

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K261057 — ActivaScrew Cannulated COM2026-09-04
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K262344 — Large Compression Screws2026-08-12
K253858 — GFS - Sterile Screws and Top Hat2026-08-05
K262075 — Lapidus Screw Kit2026-07-22

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K251400 — T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System2025-08-20
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Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.