Pangea Platform - Pangea Tibia Plating System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Stryker GmbH
Identity
- Trade Name
- Pangea EUDAMED
- Device Name
- PANGEA INSTRUMENTS - TRIALING INSTRUMENTATION - CLASS IIA - NON STERILE EUDAMED
- Model / Reference
- 08858251007129TJ EUDAMED540308T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613327657166 EUDAMED
- Basic UDI-DI
- 08858251007129TJ EUDAMED
- Direct Marketing DI
- 07613327657166 EUDAMED
- 510(k) Number
- K242445 FDA 510(k)
- FDA Product Code
- HRS FDA 510(k)
- EMDN Code
- P091280 OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES EUDAMED
- Models / Variants
- Pangea Tibia Plating System FDA 510(k)EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Pangea Platform consists of modular orthopedic plating systems designed for internal fixation of long bones, including the femur, humerus, and tibia. These systems provide rigid stabilization for complex fractures, enabling bone alignment and facilitating healing through interlocking screws and plates tailored to anatomical contours.
The Pangea systems are supplied sterile and intended for single-use in orthopedic surgical settings. Each system is regulated under FDA 510(k) clearance and EU MDR, with modular components available in standardized sizes for precise anatomical fit. Compatibility with MRI environments is not specified, and proper storage requires adherence to manufacturer guidelines to maintain sterility and functionality.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K242445 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker GmbH
Sources (2)
- FDA 510(k) K242445 24 fields · synced Sep 18, 2026
- EUDAMED 6629373f-d985-4b79-9290-ecb400a97388 61 fields · synced Jul 8, 2026