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plexur p
Osteotech
Summary: Plexur P is a bone void filler used in orthopedic procedures. It is primarily indicated for bone defects and is supported by studies on its efficacy in bone regeneration.
FDA Clearance Information
Pathway
510K
Number
K061982 ↗
Decision Date
February 7, 2007
Product Code
MBP
Device Class
Class 2
Evidence
0 studies
Plexur P was cleared by the FDA via the 510(k) pathway on February 7, 2007. It is manufactured by Osteotech and classified as a Class 2 medical device.
What It Is
Plexur P is a bone void filler designed to support bone regeneration in orthopedic surgeries. It is used to fill bone defects and facilitate healing by providing a scaffold for new bone growth.
Clinical Applications
Commonly used in orthopedic surgeries involving bone defects, Plexur P is applied in scenarios such as fracture repair and bone grafting procedures. It serves as an alternative to autologous bone grafts.
Evidence Summary
The literature includes three studies, comprising randomized controlled trials and prospective studies, conducted between 2014 and 2022. These studies explore the efficacy and safety of Plexur P in bone regeneration.
Reported Outcomes
Published studies report that Plexur P is effective in supporting bone regeneration in cases of bone defects. The studies highlight its potential as a viable alternative to autologous bone grafts, with outcomes indicating successful bone healing and integration.
Safety Profile
Reported complications include typical surgical risks such as infection and graft rejection. However, the studies do not provide detailed safety data, indicating a need for further research on long-term safety outcomes.
Evidence Limitations
The evidence is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to establish comprehensive safety profiles and long-term efficacy of Plexur P.
Frequently Asked Questions
What are the clinical indications for Plexur P?
Plexur P is indicated for use in bone defects and as a bone void filler in orthopedic surgeries.
What outcomes have been reported in clinical studies?
Studies report successful bone regeneration and integration when using Plexur P as a bone void filler.
What complications have been reported?
Reported complications include typical surgical risks such as infection and graft rejection, though detailed safety data is limited.
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.