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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 ?
510(k)
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.
FDA-Cleared Indications
- For use in hip arthroplasty to replace damaged or diseased components of the hip joint.
- Indicated for patients requiring hip joint replacement because of degenerative joint disease or other conditions affecting hip function.
- May be used in primary or revision hip arthroplasty when consistent with the specific device labeling.
Clinical Applications
- Primary total hip arthroplasty for replacement of a damaged hip joint.
- Revision total hip arthroplasty when an existing hip implant requires replacement, subject to the specific implant system labeling.
- Treatment of hip joint damage associated with degenerative joint disease.
- Replacement of hip joint components to help restore mobility and reduce pain.
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.
Practical Considerations
- The specific implant system, component sizes, fixation method, and materials must be selected according to the individual patient's anatomy and the applicable product labeling.
- Components from different implant systems should not be combined unless compatibility is specifically established by the manufacturer and labeling.
- MRI safety depends on the exact implant components and configuration; patients should provide implant information to the MRI facility for device-specific assessment.
- Contraindications, warnings, surgical technique, and postoperative restrictions vary by product and must be reviewed in the current instructions for use.
- As with other hip arthroplasty implants, possible complications include infection, dislocation, loosening, fracture, wear, leg-length difference, and revision surgery.
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.