2. The CHARITÉ™ Artificial Disc
World’s 1st commercially available artificial disc
Motion preserving technology for treating select patients with Degenerative Disc Disease (DDD)
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3. Timeline 1984 1985 1987 1989 1st prototype, SB CHARITÉ I (13 Patients)
2nd prototype,
SB CHARITÉ II
(37 Patients)
SB CHARITÉ III
Available in Europe
J.P. Lemaire,M.D. Study
100 Patients
Min 10 Year Follow-up
1994
2000
2003
2004
T. David, M.D. Study
96 Patients
Min 5 Year Follow-up
U.S. IDE
Clinical Study
First Implantation
CENTRELINE™
Instruments
Launched
FDA Approval
CENTRELINETM TDR Instruments Launched

4. Mobile-Core Design Translates to the Natural Choice
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5. Mobile-Core Design Translates to the Natural Choice
Natural motion by design
Benefits of the unique mobile-core design
Natural motion distribution may reduce adjacent level disease
Biomechanical study
Unique mobile-core design may protect facet joints
FEA
Mobile-core design translates to clinical success
The living proof
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6. Natural Motion by Design
Unique mobile-core design
Incorporates a floating center of rotation (FCOR) enabling independent rotation & translation key, components of physiologic motion
The mobile core moves dorsally during flexion and ventrally during extension
Demonstrated in Preclinical testing
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7. Natural Motion Distribution May Reduce Adjacent Level Disease
The CHARITÉ mimicked the intact spine in distribution of motion
Maintaining natural motion at all levels may reduce the potential of adjacent level disease
Cunningham BW, Godron JD, Dmitriev AE, et al: “Biomechanical Evaluation of Total Disc Replacement Arthroplasty: An In Vitro Human Cadaveric Model.” Spine 28:S110-S117, 2003.
BAK® is a registered trademark of Zimmer, Inc.
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8. Unique Mobile-Core Design May Protect Facet Joints
FEA demonstrates that the CHARITÉ Artificial Disc unloads the facets in all planes of motion
Compared to CHARITÉ, a fixed-core artificial disc increases the load of the facets
161% in axial rotation
24% in flexion/extension
35% in lateral bending
CHARITÉ
Fixed Core
Moumene M, Geisler FH. “Effect of Artificial Disc Placement on Facet Loading: Unconstrained Vs. Semi-constrained.” Presented at the 4th Annual
Meeting of the Spine Arthroplasty Society, May 5, 2004.
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9. The Living Proof CHARITÉ Translates to Clinical Success
Unprecedented long-term results published by J.P. Lemaire, M.D. support that motion is maintained over 10 years after implantation
Mean ROM 10.3º flexion/extension & 5.4º lateral bending
Lemaire JP. “SB Charité III intervertebral disc prosthesis: biomechanical, clinical, and radiological correlations with a series of 100 cases over a follow-up of more than 10 years.” Rachis [Fr] 2002;14(4):
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10. Unprecedented Clinical Results

11. Unprecedented Clinical Results
Landmark U.S. clinical trial
The CHARITÉ Artificial Disc was proven safe and effective for DDD at 1-level from L4-S1
Patients experienced
Improvement in pain and function
Maintenance of motion
Maintenance of post-operative disc height
Similar safety profile compared to anterior interbody fusion
Unparalleled long-term clinical history
Over 17 years and thousands of implantations worldwide with the current design
Proving safety, efficacy and remarkable durability

12. Patients Felt Better
Compared to baseline, the CHARITÉ Artificial Disc provided pain reduction from 6 weeks out to 24 months
Patients with the CHARITÉ Artificial Disc exhibited
49% decrease in 6-weeks
57% decrease by 24-months
Blumenthal S, McAfee P, Guyer R, Hochschuler S, Garcia R, Regan J, Ohnmeiss D. “Randomized Control Trial of the Charite Artificial Disc vs Fusion for Single Level Lumbar Degenerative Disc Disease: Two year Follow-up.” Presented at the 31st Annual Meeting of the International Society for the Study of the Lumbar Spine (ISSLS). Porto, Portugal, 2004.
BAK® is a registered trademark of Zimmer, Inc.

13. Improvement in Pain and Function
Compared to baseline, the CHARITÉ Artificial Disc provided improvement in pain and function from 6 weeks out to 24 months
Patients with the CHARITÉ Artificial Disc exhibited
25% decrease in 6-weeks
48% decrease by 24-months

14. Improvement in Pain and Function
78% of patients with the CHARITÉ Artificial Disc had at least a 10 point change in ODI
Change in ODI
CHARITÉ
BAK®
Follow-up
2 yr
> -15 pt
64%
58%
-15 to -10 pt
14% 9%
Total ≧ -10 pt
78%
67%

15. Maintained Motion
The CHARITÉ Artificial Disc allowed segmental spinal motion at the operative level

16. Maintained Disc Height
The CHARITÉ Artificial Disc provided maintenance of post-operative disc height of 12.9mm at 24-months

17. Patient Satisfaction
At 24 months, 74% of the patients with the CHARITÉ Artificial Disc were satisfied

18. Demonstrated Safety
Similar Neurological complications were observed with the the CHARITÉ Artificial Disc
Neurological Results
CHARITÉ
BAK®
Major Changes
4.4
4.0
Minor changes
13.7
16.2
Major Changes: burning or dysesthetic pain, motor deficit in index level, and nerve root injury

19. Unprecedented Long-term Results
Landmark study of 100 patients with a minimum of 10 –years follow-up by J.P Lemaire, M.D. demonstrates unprecedented results
Excellent Patient Satisfaction
90% good/excellent results
Motion Preservation
10.3º mean ROM flexion/extension
5.4 º mean ROM lateral bending
Quality of Life
92% return to work
Minimal Adjacent Level Disease
2% adjacent level disease
Lemaire JP. “SB Charité III intervertebral disc prosthesis: biomechanical, clinical, and radiological correlations with a series of 100 cases over a follow-up of more than 10 years.” Rachis [Fr] 2002;14(4):

20. Unprecedented Long-term Results
Landmark study by T. David, M.D. further supports long-term efficacy
96 patients with a minimum of 5–years follow-up
Excellent Patient Satisfaction
75% good/excellent results
Disc Height Maintenance
No loss of height
No Device Related Complications
No loosening of the UHMWPE Sliding Core
David T. “Lumbar Disc Prosthesis: Five Years Follow-Up Study on 96 Patients.” Presented at the 15th Annual Meeting of the North American Spine Society. New Orleans, Louisiana, 2000.

21. Remarkable Durability
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22. Remarkable Durability
The CHARITÉ Artificial Disc, which is comprised of cobalt chromium Endplates and Ultra High Molecular Weight Polyethylene (UHMWPE) Sliding Core, exhibits remarkable durability with:
A potential reduction in wear due to the mobile-core design
Low wear rates in biomechanical testing
No localized or systemic accumulation of wear debris
No evidence of acute neural or systemic histopathologic response
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23. Mobile-Core May Reduce Wear Potential
FEA demonstrates mobile-core design exhibits low stresses on the Endplates and Sliding Core
May significantly reduce wear potential
Under equivalent strain, a fixed-core artificial disc shows significantly higher stress
May lead to greater potential for wear
3Mpa
CHARITÉ
24Mpa
Fixed Core
Moumene M, Geisler FH. “Effect of Artificial Disc Placement on Facet Loading: Unconstrained Vs. Semi-constrained.” Presented at the 4th Annual
Meeting of the Spine Arthroplasty Society, May 5, 2004.
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24. CHARITÉ. Significantly Lower Wear Compared to Other Arthroplasty Prostheses
Bench top testing data to10 million cycles
Reportedly = 80 years of vigorous motion
Sliding Core wore at the rate of 0.11mg/Mc compared to 56mg/MC non-crosslinked Hip and 16mg/Mc crosslinked hip
Heisel C, Silva M, dela Rosa MA, et al. “Short-term in vivo wear of cross-linked polyethylene.” J Bone Joint Surg Am 2004;86-A:
Data on file
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25. Wear Debris Pre-Clinical Testing
No local or systemic accumulation of particulate wear debris nor cytokines
Baboon biomechanical study
Under extreme exposure to UHMWPE wear particulate, no evidence of acute neural or systemic histopathologic response
Rabbit studies
McAfee PC, Cunningham BW, Orbegoso CM, et al. “Analysis of porous ingrowth in intervertebral disc prostheses: a nonhuman primate model.” Spine 2003;28(4): Cunningham BW, Hallab N, Dimitriev A, Kim SW, Hu N, McAfee PC. “Epidural Application of Spinal Instrumentation Particulate Wear Debris: An In-Vitro Animal Model.” Presented at the 38th Annual Meeting of the Scoliosis Research Society. Quebec, Canada, 2003.
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26. Refined Surgical Procedure
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27. Refined Surgical Procedure
17 years of clinical experience and refinements have led to today’s CHARITÉ Artificial Disc System
Designed to replicate the patient’s natural anatomic alignment
Exceptional biomechanical design
Unparalleled range of endplates and core heights
Numerous options to help ensure proper sizing, placement and segmental lordosis
New CENTRELINE™ TDR Instrumentation for consistent and accurate sizing and midline placement for a refined surgical technique
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28. Range of Implant Options to Match Your Patients’ Anatomy
UHMWPE Sliding Core available in 5 heights ( mm) for restoration of desired disc height
Endplates available in four sizes & angles for proper sizing and restoration of segmental lordosis
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29. Intra-operative Flexibility
Angled Endplate may be placed inferiorly to help reduce shear forces and protect the implant and posterior elements
The Endplate fixation teeth maintain the integrity of the vertebral body and allow for intra-operative adjustment and removal of the CHARITÉ Artificial Disc
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30. CENTRELINE™ TDR Instrumentation
New CENTRELINE™ TDR Instrumentation aids in
consistent and accurate sizing and midline placement for optimal performance
Six Steps of Implantation
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31. 6 Steps of Implantation Step 1 Trialing
Confirm footprint size (2-5) using the Sizing Gauges
Confirm lordotic angle with the radiolucent Trials
Verify proper placement
Maximize endplate coverage
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32. Step 2 Midline Identification
Place Midline Marker using the Marker Inserter
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33. Step 3 Confirm Positioning
Confirm ability to place the CHARITÉ Artificial Disc in the proper location with the Pilot Driver
If needed, increase lordosis to initiate impaction
Shape curved surfaces prior to impaction
Place patient in neutral spine position when Pilot Driver is halfway into position
Approximately matches footprint size and height of 2 Endplates
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34. Step 4 Endplate Insertion
Insert Endplates into disc space using the Spreading and Insertion Forceps
Load thicker margin of oblique Endplate into the tips first
Place the more angled of the two Endplates inferiorly
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35. Step 5 Core Trial and Insertion
Confirm proper height with the Core Trials
Insert Sliding Core with the Core Insertion Instrument
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36. Step 6 Final Positioning
Verify proper positioning in the AP and lateral planes
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37. Delivering Excellent Results
Treatment of degenerative lumbar disc disease does not depend solely on the CHARITÉ Artificial Disc
Other important considerations include:
Completion of a company sponsored training program
Proper patient selection
Safe and adequate surgical approach and exposure to the appropriate degenerative disc level
Complete discectomy and meticulous endplate preparation
Proper implant selection and placement
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38. Natural Motion Is Back.™
The Natural Choice
Preclinical testing indicates that the unique mobile-core design incorporates a FCOR, enabling independent translation and rotation, key components of physiologic motion
Unprecedented Clinical Results
The CHARITÉ has an unparalleled long-term clinical history proving safety, efficacy and remarkable durability with over 17 years and thousands of implantations worldwide with the current design
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39. Natural Motion Is Back.™
Remarkable Durability
Significantly lower wear compared to other arthroplasty prostheses
Refined Surgical Procedure
17 years of clinical experience and refinements have led to today’s CHARITÉ Artificial Disc System
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40. Indications
The CHARITÉ™ Artificial Disc is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (DDD) at one level from L4-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients should have no more than 3mm of spondylolisthesis at the involved level. Patients receiving the CHARITÉ Artificial Disc should have failed at least six months of conservative treatment prior to implantation of the CHARITÉ Artificial Disc.
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