Graded A+
what are the 2 different ways that biologics are regulated? - 510k and HTC-p
what criteria would qualify an orthobiologic as a medical device - its an actual product,
may have xenograph, and may contain small amount of synthetic
what criteria would qualify an orthobiologic as an HCT-P - product contains 100%
human tissues
meant for homologous use
creeping substitution - grafts are temporarily structures that facilitate tissue healing. the
body removes a little bit of the graph at at time and replaces it with something better,
something native
aseptic processing - SAL 10^-3
1:1000
protects cell viability
protects the structure or integrity of the scaffold
terminal sterilization - SAL 10^-6
1:1,000,000
process includes gamma radiation or ebeam
no viable living cells
autograft - obtained from your own body
allograft - human donor
xenograft - animal donor
synthetic - man-made
cells - -genic
MSC
HSC
OPC
osteoblast
capable of rebuilding tissues that have been damaged or lost due to disease or injury
Signals - -osteoinductive
GF, Cytokine, chemokine, chemotaxis, regulator, hormone
drive and direct cellular activity
scaffold - -conductive
template, matrix
, -collagen, HA
temporary structure the body will use as a framework for its own biological process
regenerative medicine - branch of medicine concerned with developing therapies that
regenerate or replace injured or defective cells, tissues, or organs to restore or establish
function and structure
bone are classified by shape - long (femur)
short
irregular (iliac crest)
flat (scapula)
epiphysis - located at the very ends of the long bones
metaphysis - between the epiphysis and diaphysis
diaphysis - elongated, shaft
cortical bone - structural
proteins including BMP2
source of DBM
cancellous - spongy, non structural
bone marrow, MSC
osteoblast - bone formation
ossification - transformation of cartilage into bone
osteogenesis - new bone tissue formation
osteoclasts - bone resorption
continuous process
bone remodeling - coordinated effort between the osteoblast and the osteoclast to build,
resorb, repair, and refine bone
osteoporosis - bone diseases
wolff's law - A bone grows or remodels in response to forces or demands placed upon it
stress shielding - Reduction in bone density as a result of removal of normal stress from
the bone by an implant
load sharing - Allows for some of the stresses required for bone formation to be
distributed between the implant and the skeleton