Saiph Knee System
FDA 510(k)Class II (US FDA 510(k))
by Matortho
Identifiers
- 510(k) Number
- K140222 FDA 510(k)
- FDA Product Code
- JWH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3560 FDA 510(k)
- Regulation Number
- 888.3560 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SAIPH KNEE SYSTEM is a total knee prosthesis designed as a medial ball-and-socket knee system. It is intended to replicate native knee kinematics to maximize range of movement, stability, and function. The device features an evolved design based on the principle of natural asymmetry across all three compartments to improve function and patient satisfaction.
The device is supplied as a surgical system for total knee arthroplasty and is used in orthopedic settings. It is regulated under FDA 510(k) authorization with the product code JWH and review advisory committee OR. The system includes components for implantation and is designed for single-use surgical application.
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. Sources consulted: SAIPH® Knee System by MatOrtho®, The Saiph Knee - MatOrtho, PDF SAIPH Knee System - BOA, SAIPH® - Total knee prosthesis by MatOrtho | MedicalExpo
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140222 | Class II | Active |
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Manufacturer
- Manufacturer
- Matortho
Sources (1)
- FDA 510(k) K140222 24 fields · synced Sep 22, 2026