PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plati…
FDA 510(k)Class II (US FDA 510(k))
by Stryker GmbH
Identifiers
- 510(k) Number
- K222381 FDA 510(k)
- FDA Product Code
- HRS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The PeriPRO Femur System is a Plate, Fixation, Bone designed for internal fixation of femur fractures and osteotomies, including non-unions, malunions, and deformities. It incorporates a variable angle fixation system to accommodate complex anatomical challenges, such as fractures near intramedullary implants or periprosthetic fractures, in both normal and osteopenic bone.
This system is supplied as a reusable orthopedic implant, regulated under FDA 510(k) clearance (K222381) as substantially equivalent to a predicate device. It is intended for use in orthopedic surgical settings and must be handled according to sterile medical device protocols. The AxSOS 3Ti plating variant is part of the broader Stryker Plating System, adhering to orthopedic device standards and classification (Class II, HRS product code).
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: PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti ..., PeriPRO? Femur System, Variable Angle Fixation… - FDA.report, PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222381 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker GmbH
Sources (1)
- FDA 510(k) K222381 24 fields · synced Sep 19, 2026