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FDA 510(k)

PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System

K-Number: K222381 · 2023-04-27

ApplicantStryker GmbH
Decision Date2023-04-27
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System is a medical device manufactured by Stryker GmbH. It received FDA 510(k) clearance on 2023-04-27 under approval number K222381. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System?

PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System is a medical device that received FDA 510(k) clearance on 2023-04-27. It is manufactured by Stryker GmbH. The 510(k) number is K222381.

When was PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System approved by the FDA?

PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System received FDA 510(k) clearance on 2023-04-27, under approval number K222381.

What company makes PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System?

PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System is manufactured by Stryker GmbH.

What is the FDA product code for PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System?

The FDA product code for PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System is HRS.

Related Clinical Trials

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

Other Devices by Stryker GmbH

K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA) K161753Hoffman LRF System K160813EasyStep K153379AxSOS 3Ti K153377Hoffmann LRF (Limb Reconstruction Frame) System K172350AxSOS 3 Ti

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Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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