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stryker orthopaedics hip systems labeling update
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Summary: The Stryker Orthopaedics Hip Systems are designed for hip arthroplasty procedures. Key evidence highlights include a revision estimate of 2.8% for the Exeter V40 stem in primary THA.
FDA Clearance Information
Pathway
510K
Number
K240418 ↗
Decision Date
April 12, 2024
Product Code
JDI
Device Class
Class 2
Evidence
0 studies
The Stryker Orthopaedics Hip Systems received FDA 510(k) clearance on April 12, 2024. Manufactured by Howmedica Osteonics Corp., the device is classified as Class 2 under product code JDI.
What It Is
The Stryker Orthopaedics Hip Systems are orthopedic devices used in hip arthroplasty. They are designed to replace or repair hip joints, providing stability and mobility for patients with hip joint issues.
Clinical Applications
These hip systems are commonly used in primary and revision total hip arthroplasty procedures. They are particularly useful in cases requiring smaller stem sizes or specific anatomical considerations.
Evidence Summary
The available literature includes five studies, comprising various study types such as RCTs and retrospective analyses, with publication years ranging from 2020 to 2023.
Reported Outcomes
Published studies report a revision estimate of 2.8% for the Exeter V40 stem in primary THA. The ten-year revision estimate for the 44/00/125 stem is 4.9%, with a hazard ratio of 1.8 compared to other Exeter V40 stems.
Safety Profile
Reported complications include an increased revision estimate for the Exeter V40 stem, with a noted hazard ratio of 1.8 compared to other stems. Surgeons and patients should be aware of this increased risk.
Evidence Limitations
The evidence is limited by the small number of studies focusing specifically on the Stryker Orthopaedics Hip Systems. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Stryker Orthopaedics Hip Systems?
The systems are indicated for use in primary and revision total hip arthroplasty procedures, particularly in cases requiring specific anatomical considerations.
What outcomes have been reported in clinical studies?
Clinical studies report a revision estimate of 2.8% for the Exeter V40 stem and a ten-year revision estimate of 4.9% for the 44/00/125 stem.
What complications have been reported?
Safety data indicate an increased revision estimate for the Exeter V40 stem, with a hazard ratio of 1.8 compared to other stems.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.