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osteoselect demineralized bone matrix putty
Bacterin International
Summary: OsteoSelect Demineralized Bone Matrix Putty is a bone graft substitute used in orthopedic procedures. It is FDA 510(k) cleared and has been studied for its osteogenic potential compared to synthetic alternatives.
FDA Clearance Information
Pathway
510K
Number
K130498 ↗
Decision Date
May 31, 2013
Product Code
MBP
Device Class
Class 2
Evidence
0 studies
OsteoSelect Demineralized Bone Matrix Putty was cleared via the FDA 510(k) pathway on May 31, 2013. It is manufactured by Bacterin International and classified as a Class 2 medical device.
What It Is
OsteoSelect Demineralized Bone Matrix Putty is a bone graft substitute designed to support bone regeneration. It is used in various orthopedic applications to fill bone defects and promote osteogenesis.
Clinical Applications
Commonly used in orthopedic surgeries, OsteoSelect Putty is applied to fill bone voids or defects that are not intrinsic to the stability of the bony structure. It is particularly useful in cranial and other skeletal reconstructions.
Evidence Summary
Two studies have evaluated OsteoSelect Putty, focusing on its osteogenic potential and the effects of temperature exposure during shipment. These studies were conducted between 2013 and 2017.
Reported Outcomes
Published studies report that OsteoSelect Putty has comparable osteogenic potential to synthetic alternatives in cranial defect models. The studies did not provide specific quantitative outcomes but indicated effective bone regeneration.
Safety Profile
Reported complications include potential temperature sensitivity during shipment, which could affect the product's efficacy. No direct adverse events were detailed in the studies provided.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed quantitative outcomes. Further research is needed to explore long-term efficacy and safety in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for OsteoSelect Demineralized Bone Matrix Putty?
OsteoSelect Putty is indicated for filling bone voids or defects in orthopedic procedures, particularly in cranial and skeletal reconstructions.
What outcomes have been reported in clinical studies?
Studies report that OsteoSelect Putty has comparable osteogenic potential to synthetic alternatives, effectively supporting bone regeneration.
What complications have been reported?
Reported complications include potential temperature sensitivity during shipment, which may affect product efficacy.
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.