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stryker orthopaedics hip systems labeling update
Stryker Orthopaedics
Summary: The Stryker Orthopaedics Hip Systems are designed for hip arthroplasty procedures. Primarily used in total hip replacements, key evidence highlights a 4.9% ten-year revision estimate for specific stems.
FDA Clearance Information
Pathway
510K
Number
K153345 ↗
Decision Date
May 25, 2016
Product Code
LPH
Device Class
Class 2
Evidence
0 studies
The Stryker Orthopaedics Hip Systems were cleared via the FDA 510k pathway on May 25, 2016. Manufactured by Stryker Orthopaedics, these devices are classified as Class 2 under product code LPH.
What It Is
The Stryker Orthopaedics Hip Systems are medical devices used in hip arthroplasty to replace or revise hip joints. They are designed to provide stability and mobility for patients undergoing hip replacement surgery.
Clinical Applications
These hip systems are commonly used in primary and revision total hip arthroplasty procedures. They are particularly useful in cases requiring specific stem sizes or offsets to accommodate patient anatomy.
Evidence Summary
The available literature includes various study types such as RCTs and retrospective analyses, with a total of 5 studies reviewed. The studies span from 2020 to 2023, providing insights into the device's performance.
Reported Outcomes
Published studies report a 2.8% overall revision estimate for the Exeter V40 stem used in primary total hip arthroplasty. Specifically, the 44/00/125 stem shows a 4.9% ten-year revision estimate. A hazard ratio of 1.8 was noted for this stem compared to other Exeter V40 stems.
Safety Profile
Reported complications include an increased revision estimate for certain stem types. Surgeons and patients should be aware of the observed increased revision estimate associated with the 44/00/125 stem.
Evidence Limitations
The evidence is limited by the lack of randomized controlled trials specifically evaluating the Stryker Orthopaedics Hip Systems. Further research is needed to assess long-term outcomes and safety across 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.
What outcomes have been reported in clinical studies?
Studies report a 2.8% overall revision estimate and a 4.9% ten-year revision estimate for the 44/00/125 stem.
What complications have been reported?
Reported complications include an increased revision estimate for the 44/00/125 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.