đź“Š Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Total hip arthroplasty for patients with painful and disabling hip joint disease.
- Replacement of the femoral head and acetabulum when the hip joint is damaged by degenerative or traumatic conditions.
- Use of acetabular shells and femoral stems with compatible components and instruments during the direct superior approach to the hip.
Clinical Applications
- Primary total hip replacement for osteoarthritis or other degenerative joint disease.
- Total hip replacement for rheumatoid arthritis or other inflammatory joint disease when the hip is painful and functionally limiting.
- Hip replacement after femoral neck or other proximal femur fractures when reconstruction of the joint is indicated.
- Cementless fixation of compatible acetabular and femoral components when adequate bone quality and fixation are present.
- Use of the associated instruments during total hip arthroplasty performed through a direct superior surgical approach.
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.
Practical Considerations
- The shells, stems, liners, femoral heads, and other components must be compatible within the selected implant system; sizes and offsets are chosen from preoperative imaging and intraoperative assessment.
- The direct superior approach is a surgical technique, not a separate implant type. Patient selection and the surgeon's experience with the approach affect component positioning and outcomes.
- Cementless components require sufficient bone quality and initial stability for biologic fixation. Severe bone loss, infection, or inadequate fixation may require another reconstructive strategy.
- MRI safety depends on the complete implanted construct and the manufacturer's current labeling. Patients should provide the implant identification information before MRI.
- Potential complications include infection, fracture, loosening, wear, leg-length or offset changes, nerve injury, and dislocation. The instruments are reusable surgical tools and must be inspected, cleaned, sterilized, and handled according to the instructions for use.
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.