đź“Š Evidence-Based Reference
Special Orthopaedic Solutions Glenoid Shoulder Component
Howmedica Osteonics
Summary: The Special Orthopaedic Solutions Glenoid Shoulder Component is a medical device used in shoulder arthroplasty. It is primarily used for shoulder stabilization. Key evidence highlights its role in managing shoulder instability.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K103104 ↗
Decision Date ?
November 22, 2010
Product Code ?
KWS
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510(k) pathway on November 22, 2010. It is manufactured by Howmedica Osteonics and is classified as a Class 2 medical device.
What It Is
The Special Orthopaedic Solutions Glenoid Shoulder Component is designed for use in shoulder arthroplasty procedures. It serves to replace or augment the glenoid component of the shoulder joint, providing stability and support in cases of shoulder instability.
FDA-Cleared Indications
- Use as a glenoid component in shoulder arthroplasty.
- Use in reconstruction or replacement of the glenoid side of the shoulder joint when indicated for shoulder arthroplasty.
Clinical Applications
- Glenoid replacement during primary shoulder arthroplasty.
- Glenoid reconstruction during revision shoulder arthroplasty.
- Treatment of shoulder joint conditions requiring replacement of the glenoid component, as determined by the treating surgeon.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs, prospective, and retrospective studies. The studies span from 2024 to 2025, providing insights into the device's clinical applications.
Reported Outcomes
Published studies report that the device is effective in stabilizing the shoulder joint, particularly in cases of posterior and anterior shoulder instability. It has been shown to reduce recurrence rates of shoulder dislocation in adolescents and improve outcomes in reverse total shoulder arthroplasty.
Safety Profile
Reported complications include issues related to the revision of reverse total shoulder arthroplasty and potential complications from imaging requirements. Some studies highlight the need for additional imaging, which may expose patients to increased radiation.
Evidence Limitations
The evidence is limited by the relatively short follow-up periods and the need for more comprehensive studies on long-term outcomes. Further research is needed to explore the full range of complications and the device's efficacy in diverse patient populations.
Practical Considerations
- The component is available in specific sizes and configurations; the surgeon selects the implant based on glenoid anatomy, bone quality and the planned arthroplasty system.
- Compatibility with the humeral component, instrumentation and other implants must be confirmed before surgery.
- Implant handling, fixation and preparation of the glenoid should follow the manufacturer’s instructions for use.
- MRI safety depends on the complete implanted system and its materials. The patient should provide the implant identification information to the MRI facility before imaging.
- Contraindications and precautions may include infection, inadequate bone stock, poor soft-tissue support, or medical conditions that make arthroplasty unsafe.
Frequently Asked Questions
What are the clinical indications for Special Orthopaedic Solutions Glenoid Shoulder Component?
The device is indicated for use in shoulder arthroplasty to address shoulder instability, particularly in cases requiring glenoid component replacement or augmentation.
What outcomes have been reported in clinical studies?
Studies report effective stabilization of the shoulder joint and reduced recurrence of dislocation, particularly in adolescent patients.
What complications have been reported?
Safety data indicate complications related to revision procedures and increased radiation exposure from additional imaging requirements.
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.