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Stryker Orthopaedics Hip Systems Labeling Update
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Summary: The Stryker Orthopaedics Hip Systems, manufactured by Howmedica Osteonics Corp., are used in hip arthroplasty procedures. Key evidence highlights include a 4.9% ten-year revision estimate for the Exeter V40 short revision stem.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K233498 ↗
Decision Date ?
December 21, 2023
Product Code ?
LPH
Device Class ?
Class 2
Evidence ?
0 studies
The Stryker Orthopaedics Hip Systems were cleared through the FDA 510(k) pathway on December 21, 2023. Manufactured by Howmedica Osteonics Corp., these devices are classified as Class 2 under product code LPH.
What It Is
The Stryker Orthopaedics Hip Systems are medical devices designed for use in hip arthroplasty procedures. They are intended to replace or revise hip joints, providing stability and mobility for patients with hip joint issues.
FDA-Cleared Indications
- Use in total hip arthroplasty to replace a diseased or damaged hip joint.
- Use in revision hip arthroplasty when an existing hip replacement requires replacement or revision.
- Use of available component sizes and offsets to accommodate the patient's femoral and acetabular anatomy.
Clinical Applications
- Primary total hip replacement for a painful or damaged hip joint.
- Revision total hip replacement for failed, loose, worn, or otherwise compromised hip components.
- Selection of smaller femoral stem sizes when required by the patient's femoral anatomy.
- Selection of different femoral offsets to help restore hip biomechanics and joint stability.
Evidence Summary
The available literature includes five studies, with types ranging from randomized controlled trials to case series. The studies span from 2020 to 2023, providing insights into the clinical performance of the hip systems.
Reported Outcomes
Published studies report a 2.8% revision estimate for the Exeter V40 stem in primary total hip arthroplasty. 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 44/00/125 stem. Surgeons and patients should be aware of this potential risk when considering the device for hip arthroplasty.
Evidence Limitations
The evidence is limited by the lack of randomized controlled trials specifically addressing the Stryker Orthopaedics Hip Systems. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Practical Considerations
- The system includes multiple component designs, sizes, and offsets; the surgeon selects components based on imaging, bone quality, anatomy, and surgical findings.
- Compatibility is limited to the labeled components and approved combinations; components from different systems or manufacturers should not be mixed unless specifically permitted by labeling.
- Hip arthroplasty requires surgery with anesthesia or sedation and carries risks such as infection, dislocation, fracture, loosening, leg-length difference, wear, and the need for revision.
- MRI safety depends on the specific implanted components and their current conditions for use. Patients should identify the exact implant before MRI, and the imaging facility should follow the manufacturer's MRI labeling.
- The device is not appropriate for every patient; active infection, inadequate bone stock, severe medical comorbidity, or other contraindications may affect eligibility.
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 when specific stem sizes or offsets are required.
What outcomes have been reported in clinical studies?
Clinical studies have reported a 2.8% revision estimate for the Exeter V40 stem 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, highlighting the need for careful consideration in its use.
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.