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stryker orthopaedics acetabular shells femoral stems and total hip instruments for use with the direct superior approach
Stryker Orthopaedics
Summary: The Stryker Orthopaedics acetabular shells and femoral stems are used in total hip arthroplasty, particularly with the direct superior approach. Key evidence highlights their efficacy in reducing dislocation rates and improving implant survival.
FDA Clearance Information
Pathway
510K
Number
K143085 ↗
Decision Date
February 9, 2015
Product Code
LPH
Device Class
Class 2
Evidence
0 studies
The device was cleared via the FDA 510(k) pathway on February 9, 2015, by Stryker Orthopaedics. It is classified as a Class 2 medical device under product code LPH.
What It Is
The Stryker Orthopaedics acetabular shells and femoral stems are components used in total hip arthroplasty. They are designed for use with the direct superior approach, providing stability and durability in hip replacement surgeries.
Clinical Applications
These devices are commonly used in total hip arthroplasty procedures, particularly in cases requiring cementless fixation. They are suitable for patients with hip joint degeneration or fractures requiring joint replacement.
Evidence Summary
The available literature includes 13 studies, comprising randomized controlled trials, cohort studies, and case series, conducted between 2020 and 2024. These studies evaluate the clinical outcomes and safety of the acetabular shells and femoral stems.
Reported Outcomes
Published studies report that the Stryker Orthopaedics acetabular shells demonstrate reduced dislocation rates and improved implant survival. The hydroxyapatite-coated titanium shells show favorable migration and clinical outcomes over a two-year period.
Safety Profile
Reported complications include dislocation and implant failure, although dual-mobility constructs have been shown to mitigate these risks. Cemented dual-mobility constructs in uncemented shells have demonstrated satisfactory implant survival and radiological outcomes.
Evidence Limitations
Some studies have limited follow-up durations, and further research is needed to assess long-term outcomes. The variability in study designs and patient populations may affect the generalizability of the findings.
Frequently Asked Questions
What are the clinical indications for Stryker Orthopaedics acetabular shells?
The device is indicated for use in total hip arthroplasty, particularly in patients requiring cementless fixation and those undergoing the direct superior approach.
What outcomes have been reported in clinical studies?
Studies report reduced dislocation rates, improved implant survival, and favorable migration outcomes for the acetabular shells.
What complications have been reported?
Safety data indicate potential complications such as dislocation and implant failure, though dual-mobility constructs may reduce these risks.
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.