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Improved Passivation Method for Metallic Orthopaedic Implants
Smith & Nephew Richards
Summary: The improved passivation method for metallic orthopaedic implants by Smith & Nephew Richards is designed to enhance implant longevity and biocompatibility. Key evidence highlights its potential in reducing oxidation and improving implant stability.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K934590 ↗
Decision Date ?
June 14, 1995
Product Code ?
HWC
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510(k) pathway on June 14, 1995, by Smith & Nephew Richards. It is classified as a Class 2 medical device under product code HWC.
What It Is
This device employs an advanced passivation technique to improve the surface properties of metallic orthopaedic implants, aiming to reduce corrosion and enhance biocompatibility. It is intended for use in orthopaedic surgeries to improve implant longevity.
FDA-Cleared Indications
- Use as a passivation treatment for metallic orthopedic implant components.
- Treatment intended to improve the corrosion resistance and surface properties of metallic orthopedic implants.
- Use with metallic orthopedic implants in orthopedic surgical applications covered by the device labeling.
Clinical Applications
- Passivation of metallic components used in joint replacement implants.
- Passivation of metallic components used in fracture-fixation implants.
- Surface treatment of metallic orthopedic implants before clinical use.
- Use when improved corrosion resistance and biocompatibility of a metallic implant surface are desired.
Evidence Summary
The available literature includes 10 studies, primarily focusing on the passivation process and its effects on implant stability. These studies range from 2024 to 2025 and include various research types, though specific clinical outcomes are not detailed.
Reported Outcomes
Published studies report that the improved passivation method may enhance the stability and longevity of metallic implants by reducing oxidation. However, specific clinical efficacy outcomes are not detailed in the provided evidence.
Safety Profile
Reported complications include potential issues related to the passivation process itself, though specific adverse events are not detailed in the provided studies. Further research is needed to fully understand the safety profile.
Evidence Limitations
The evidence lacks detailed clinical outcomes and safety data, highlighting a need for further research to establish comprehensive efficacy and safety profiles. Current studies focus more on the technical aspects of the passivation process.
Practical Considerations
- This is a manufacturing or surface-treatment method rather than an independently implanted device; the implant's own labeling determines its permitted clinical use.
- Compatibility depends on the implant metal, alloy, coating, geometry, and processing specifications.
- Handling and sterilization must follow the implant manufacturer's instructions because additional processing can affect the treated surface.
- MRI safety is determined by the finished implant and its components, not by passivation alone; review the implant's MRI labeling.
- Contraindications, warnings, sizes, and expected service life are specific to the finished orthopedic implant.
Frequently Asked Questions
What are the clinical indications for improved passivation method for metallic orthopaedic implants?
The device is indicated for use in orthopaedic surgeries requiring metallic implants, particularly where enhanced stability and reduced corrosion are desired.
What outcomes have been reported in clinical studies?
Studies suggest improved implant stability and reduced oxidation, but specific clinical outcomes are not detailed in the provided evidence.
What complications have been reported?
Reported complications include potential issues with the passivation process, though specific adverse events are not detailed in the evidence.
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.