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stryker orthopaedics hip devices labeling update
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Summary: Stryker Orthopaedics hip devices, manufactured by Howmedica Osteonics Corp., are used in hip arthroplasty. Key evidence highlights include survival rates and revision estimates from clinical studies.
FDA Clearance Information
Pathway
510K
Number
K243784 ↗
Decision Date
February 6, 2025
Product Code
LPH
Device Class
Class 2
Evidence
0 studies
The Stryker Orthopaedics hip devices were cleared through the FDA 510(k) pathway on February 6, 2025. Manufactured by Howmedica Osteonics Corp., these devices are classified as Class 2 under product code LPH.
What It Is
Stryker Orthopaedics hip devices are designed for hip arthroplasty procedures. They function by replacing damaged hip joints to restore mobility and reduce pain. These devices are intended for use in patients requiring hip joint replacement.
Clinical Applications
These devices are commonly used in primary and revision total hip arthroplasty. They are suitable for patients with degenerative joint diseases or those requiring revision due to previous implant failure.
Evidence Summary
The available literature includes four studies, comprising pilot studies and retrospective analyses, conducted between 2020 and 2023. These studies provide insights into device performance and patient outcomes.
Reported Outcomes
Published studies report a revision estimate of 2.8% for the Exeter V40 short revision stem in primary total hip arthroplasty. The ten-year revision estimate for the 44/00/125 stem is 4.9%. A hazard ratio of 1.8 was observed for this stem compared to other Exeter V40 stems.
Safety Profile
Reported complications include an increased revision estimate for the 44/00/125 stem. Surgeons and patients should be aware of this potential risk when considering device options.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of randomized controlled trials. Further research is needed to confirm long-term outcomes and safety profiles.
Frequently Asked Questions
What are the clinical indications for Stryker Orthopaedics hip devices?
Stryker Orthopaedics hip devices are indicated for use in patients requiring primary or revision total hip arthroplasty due to degenerative joint diseases or implant failure.
What outcomes have been reported in clinical studies?
Clinical studies have reported a revision estimate of 2.8% for the Exeter V40 short revision stem and a ten-year revision estimate of 4.9% for the 44/00/125 stem.
What complications have been reported?
Reported complications include an increased revision estimate for the 44/00/125 stem, highlighting the need for careful consideration in device selection.
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.