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FACETEDTHREADFORMTECHNOLOGY
The New Fixation Standard in Orthopedics
dfd
Biomechanical Characteristics
Hel
ical Screw
Less Risk of Excessive Localized Compression
During Insertion
INSERTIONAL TORQUE~50% less than competitor
[A]
1
2
3
TorqueNm
Less Risk of Excessive Localized Compressive Stress During Insertion
Diamond Screw
0
~
Biomechanical Characteristics
DMD_SML_022_D || Version 1.0 - PROPRIETARY AND CONFIDENTIAL Biomechanical Features
Insertional Torque 40% to 50% less than competitor [A]
Insertional Characteristics
Torque Conversion 50% greater than competitor at 3.5 Nm [A]
Fixation Integrity Improved fixation demonstrated in toggle test [B]
Torque Nm
2 0
1
3
Graph Color Legend: Diamond Synthes
[A, B] Based on studies conducted at OrthoKinetic Testing Technologies; tested in biological and non-biological test substrates. Data on file.
Less Compressive Stress of Bone;
Less Risk of Necrosis
Less Risk of Excessive Localized Compression During Insertion
Less Risk of Screw Loosening
Due to Cyclic Loading
Max
imum
Dis
plac
emen
t
Cycles (MM)
Less Risk ofScrew Loosening
Due to Cyclic Loading
1 2 3
Applied Torque [N-m]
1200
800
400
Less CompressiveStress of Bone;
Less Risk of Necrosis
Axia
l Loa
d [
N]
Diamond SynthesGraph Color Legend:
TORQUE CONVERSION50% greater than competitor at 3.5 Nm[A]
0 0.5 1 1.5 2 2.5
1 2 3
Applied Torque [N-m]
1200
800
400
Less CompressiveStress of Bone;
Less Risk of Necrosis
Axia
l Loa
d [
N]
TORQUE CONVERSION50% greater than competitor at 3.5 Nm[A]
FIXATION INTEGRITYImproved fixation demonstrated in toggle test[A]
~ [A]
[A] Based on studies conducted at Orthokinetic Testing Technologies; tested in biological and non-biological test substrates. Data on file.
Diamond HelicalGraph Color Legend:
Diamond Orthopedic bone screws feature an enhanced design where facets are addedto screw threads, increasing thread volume,
fostering better engagement with neighboring bone, and lowering compressive stress.
Facets create ‘peaks’ and ‘valleys’ on screw threads. The ‘peaks’ serve as the initial area of bone/screw con-
tact during insertion, which reduces friction and results in ~50%
less torque required for insertion.
Immediately following insertion, bone re-laxes into facet ‘valleys,’ enabling greater
bone/screw contact than the typical helical screw.
(See pullout strength comparison next page)
Facets bring a“volumetric advantage,”
with thread valleys holding up to20% more bone volume, enabling greaterpullout strength and toggle performance.
2
REVOLUTIONARY THREADFORM
Diamond Orthopedic’s Proprietary Bone ScrewTechnology Is Revolutionizing Orthopedic Fixation
[B] Based on in vivo ovine testing conducted at OrthoKinetic Testing Technologies as compared to market leading helical screw with same profile.Additional validation testing has been performed in non-biological substrates. Data on file.
[A] Based on studies conducted at Orthokinetic Testing Technologies; tested in biological and non-biological test substrates. Data on file.
THE FACET ANSWERTO COMPRESSIVE STRESS
INSERTION - Less Stress of Bone
FIXATION INNOVATION
POST-INSERTION - Bone Engagement
Compressive stress generated by traditional threads can cause microfractures, damage bone, and can create a narrow, high-stress core susceptible to pullout failure. A faceted screw’s ability to generate lower compressive stress brings a new and unique way to address this issue.
Diamond Faceted Screw Out-Performs Market Leading Helical Screw In Pullout StrengthIn an in vivo ovine study, the Diamond Orthopedic faceted screw demonstrated statistically significant 61% greater pullout strength within 2 weeks of surgery.
20%GREATER PULLOUT
STRENGTH
0 WEEKS
61%GREATER PULLOUT
STRENGTH
2 WEEKS
After insertion, the facet “valleys” also promote restoration of bone against the screw flanks, creating a firm grip that increases fixation and retention strength, and reduces post-insertion compressive stress. Faceted screws distribute the load over a greater volume of bone and significantly increase the peak pullout load.[B]]
The faceted thread’s unique design reduces friction during insertion. Facet ‘valleys’ serve as a bone stress ‘relief mechanism,’ resulting in ~50% lower insertional torque and less potential for microfractures and necrosis.
PULLOUT STRENGTH (POST-OP)
[B] Based on in vivo ovine testing conducted at OrthoKinetic Testing Technologies as compared to market leading helical screw with same profile.Additional validation testing has been performed in non-biological substrates. Data on file.
[B]
Biomechanical Characteristics
DMD_SML_022_D || Version 1.0 - PROPRIETARY AND CONFIDENTIAL Biomechanical Features
Insertional Torque 40% to 50% less than competitor [A]
Insertional Characteristics
Torque Conversion 50% greater than competitor at 3.5 Nm [A]
Fixation Integrity Improved fixation demonstrated in toggle test [B]
Torque Nm
2 0
1
3
Graph Color Legend: Diamond Synthes
[A, B] Based on studies conducted at OrthoKinetic Testing Technologies; tested in biological and non-biological test substrates. Data on file.
Less Compressive Stress of Bone;
Less Risk of Necrosis
Less Risk of Excessive Localized Compression During Insertion
Less Risk of Screw Loosening
Due to Cyclic Loading
Max
imum
Dis
plac
emen
t
Cycles (MM)
Less Risk ofScrew Loosening
Due to Cyclic Loading
1 2 3
Applied Torque [N-m]
1200
800
400
Less CompressiveStress of Bone;
Less Risk of Necrosis
Axia
l Loa
d [
N]
Diamond SynthesGraph Color Legend:
TORQUE CONVERSION50% greater than competitor at 3.5 Nm[A]
0 0.5 1 1.5 2 2.5
1 2 3
Applied Torque [N-m]
1200
800
400
Less CompressiveStress of Bone;
Less Risk of Necrosis
Axia
l Loa
d [
N]
TORQUE CONVERSION50% greater than competitor at 3.5 Nm[A]
Diamond Helical
Biomechanical Characteristics
DMD_SML_022_D || Version 1.0 - PROPRIETARY AND CONFIDENTIAL Biomechanical Features
Insertional Torque 40% to 50% less than competitor [A]
Insertional Characteristics
Torque Conversion 50% greater than competitor at 3.5 Nm [A]
Fixation Integrity Improved fixation demonstrated in toggle test [B]
Torque Nm
2 0
1
3
Graph Color Legend: Diamond Synthes
[A, B] Based on studies conducted at OrthoKinetic Testing Technologies; tested in biological and non-biological test substrates. Data on file.
Less Compressive Stress of Bone;
Less Risk of Necrosis
Less Risk of Excessive Localized Compression During Insertion
Less Risk of Screw Loosening
Due to Cyclic Loading
Max
imum
Dis
plac
emen
t
Cycles (MM)
Less Risk ofScrew Loosening
Due to Cyclic Loading
1 2 3
Applied Torque [N-m]
1200
800
400
Less CompressiveStress of Bone;
Less Risk of Necrosis
Axia
l Loa
d [
N]
Diamond SynthesGraph Color Legend:
TORQUE CONVERSION50% greater than competitor at 3.5 Nm[A]
0 0.5 1 1.5 2 2.5
1 2 3
Applied Torque [N-m]
1200
800
400
Less CompressiveStress of Bone;
Less Risk of Necrosis
Axia
l Loa
d [
N]
TORQUE CONVERSION50% greater than competitor at 3.5 Nm[A]
3[A] Based on studies conducted at Orthokinetic Testing Technologies; tested in biological and non-biological test substrates. Data on file.
1600 Camden RoadCharlotte, NC [email protected]
Diamond Orthopedic offersfaceted threadform technology fororthopedic applications worldwide