Filler, Bone Void, Synthetic Peptide
The synthetic peptide bone void filler is an orthopedic implant device consisting of a filling material combined with a synthetic peptide, intended to fill traumatic or surgically created bone defects in the extremities, spine, or pelvis, with the material resorbing over time as bone regenerates. It is classified as FDA Class 3, the highest risk category, requiring Premarket Approval (PMA) due to insufficient evidence that general or special controls alone can ensure safety and effectiveness. Product code NOX carries both implant and life-sustaining flags and has no regulation number, as it is an unclassified Class 3 device reviewed by the Orthopedic panel.
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Basic Information
- Product Code
- NOX
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- OR
- Submission Type
- 2
Device Characteristics
Definition
The device acts as a bone void filler and consists of a filling material and a synthetic peptide. It is intended to fill traumatic or surgically-created defects that are not intrinsic to the bony structure of the extremities, spine or pelvis. It will be packed or placed into the defect and will resorb over time to be replaced by bone.
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.