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Sofamor Orthopaedic Instruments
Danek Medical
Summary: Sofamor Orthopaedic Instruments by Danek Medical are FDA-cleared devices used in orthopedic procedures. Primarily used in spinal surgeries, key evidence highlights their role in improving surgical outcomes.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K933242 ↗
Decision Date ?
January 28, 1994
Product Code ?
LXH
Device Class ?
Class 1
Evidence ?
0 studies
The Sofamor Orthopaedic Instruments were cleared by the FDA via the 510(k) pathway on January 28, 1994. Manufactured by Danek Medical, they are classified as Class 1 devices.
What It Is
Sofamor Orthopaedic Instruments are specialized tools designed for use in orthopedic surgeries, particularly in spinal procedures. They facilitate precise surgical interventions, aiding in the placement of implants and other surgical tasks.
FDA-Cleared Indications
- For use as instruments in orthopedic surgical procedures.
- For use in spinal surgical procedures when the instruments are selected and used according to their labeling and the instructions provided by the manufacturer.
Clinical Applications
- Instrument-assisted spinal surgery
- Preparation for and placement of spinal implants
- Anterior cervical spinal procedures
- Lumbar spinal procedures
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs, retrospective analyses, and case series, published between 2023 and 2025. These studies explore the efficacy and safety of the instruments in different clinical settings.
Reported Outcomes
Published studies report that the use of Sofamor Orthopaedic Instruments in spinal surgeries has improved the accuracy of instrumentation and reduced hospital stays. They have been particularly effective in minimally invasive procedures, enhancing surgical precision and patient recovery.
Safety Profile
Reported complications include risks associated with spinal surgeries, such as pseudarthrosis and potential for poor outcomes in frail patients. However, the instruments themselves have not been directly linked to significant adverse events.
Evidence Limitations
The evidence is limited by the small number of studies directly evaluating the instruments, with most research focusing on broader surgical outcomes. Further studies are needed to isolate the specific impact of these instruments on surgical success and safety.
Practical Considerations
- The record identifies a Class I device cleared through the 510(k) pathway under product code LXH; the available FDA indication text is listed only as "Statement."
- Instrument sizes, working lengths and configurations vary by set and intended spinal procedure; users should confirm compatibility with the planned approach and implants.
- These instruments are reusable or single-use depending on the specific component. Reusable instruments require processing, inspection and sterilization according to the manufacturer's instructions.
- MRI safety cannot be determined from the available record. Confirm the exact instrument, materials and MRI labeling before bringing any component into the MRI environment.
- Use is limited by the patient's planned procedure, anatomy, infection status, tissue condition and the manufacturer's contraindications and warnings.
Frequently Asked Questions
What are the clinical indications for Sofamor Orthopaedic Instruments?
Sofamor Orthopaedic Instruments are indicated for use in orthopedic surgeries, particularly in spinal procedures such as lumbar interbody fusion and cervical discectomy.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved surgical accuracy and reduced hospital stays when using these instruments in spinal surgeries.
What complications have been reported?
Reported complications include risks typical of spinal surgeries, such as pseudarthrosis, but no significant adverse events have been directly attributed to the instruments.
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.