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Orthopaedic Staples
Ortho Spectrum
Summary: Orthopaedic staples by Ortho Spectrum are used in surgical procedures for tissue fixation. Key evidence highlights their use in controlling bleeding and potential complications like implant migration.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K890962 ↗
Decision Date ?
May 15, 1989
Product Code ?
JDR
Device Class ?
Class 2
Evidence ?
0 studies
The orthopaedic staples by Ortho Spectrum were cleared through the FDA 510(k) pathway on May 15, 1989. They are classified as Class 2 medical devices.
What It Is
Orthopaedic staples are medical devices used for the fixation of tissues during surgical procedures. They are designed to provide secure and reliable closure, particularly in orthopaedic surgeries.
FDA-Cleared Indications
- Fixation and approximation of tissue during orthopaedic surgical procedures.
- Use when surgical staples are indicated for securing tissue or bone in the intended operative setting.
Clinical Applications
- Tissue approximation during orthopaedic surgery
- Fixation during trauma-related orthopaedic procedures
- Fixation during reconstructive orthopaedic procedures
- Rapid closure or stabilization of tissue when staples are selected by the surgeon
Evidence Summary
The available literature includes 9 studies, comprising case reports and clinical trials, with publication dates ranging from 1987 to 2025. These studies explore various aspects of staple use, including efficacy and safety.
Reported Outcomes
Published studies report that orthopaedic staples are effective in controlling bleeding in critical situations, such as iliac venous and aortic hemorrhages. They have also been used successfully in limb-sparing surgeries. However, there are rare reports of complications such as migration leading to bladder perforation.
Safety Profile
Reported complications include rare instances of staple migration, which can lead to serious outcomes such as bladder perforation. The risk of infection and antimicrobial resistance is also a concern, as highlighted in studies examining biofilm formation on implants.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to fully understand the long-term safety and efficacy of orthopaedic staples, particularly regarding infection risks and implant migration.
Practical Considerations
- Staples are available in different sizes and configurations; selection depends on the tissue, bone, and procedure.
- The device should be used only with compatible instruments and according to the manufacturer’s labeling.
- Implant migration, loss of fixation, tissue injury, infection, and bleeding are possible complications.
- MRI safety depends on the staple material, configuration, and labeling. The specific device should be identified before MRI, and its current MRI conditions should be verified.
- Contraindications and precautions include infection at the operative site, inadequate tissue or bone quality, and situations in which secure staple fixation cannot be achieved.
Frequently Asked Questions
What are the clinical indications for orthopaedic staples?
Orthopaedic staples are indicated for tissue fixation in surgical procedures, particularly in orthopaedic surgeries.
What outcomes have been reported in clinical studies?
Studies report effective bleeding control and successful use in limb-sparing surgeries, with rare complications like migration.
What complications have been reported?
Safety data indicate rare complications such as staple migration leading to bladder perforation and potential infection 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.