Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System— 510(k) K231262

Name: FDA 510(k) clearance K231262
Creator: U.S. Food and Drug Administration
Published: 2023-08-18

Substantially Equivalent

Stryker GmbH

FDA 510(k) clearance K231262 for Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System, Substantially Equivalent on 2023-08-18. 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: 2023-05-01
Decision date: 2023-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahwah, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRS

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K261647 — Tempo Plating System; Ultra Compression Screw System2026-09-03
K261830 — FRAXION 3.5 Plate System (Various - See Catalog) +3 more2026-08-28
K262537 — Versalock Sterile Plating System2026-08-19
K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM2026-08-13
K261511 — Xpert Ankle2026-07-28

More clearances from Stryker GmbH

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K261481 — Pangea Femur Reconstruction System2026-06-29
K253640 — T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System2026-02-03
K253202 — Hoffmann LRF System2025-12-19
K251400 — T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System2025-08-20
K250163 — T2 Alpha Femur Retrograde Nailing System2025-08-13

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.