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TOTAL HIP ARTHROPLASTY SOLUTIONS

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Page 1: TOTAL HIP ARTHROPLASTY SOLUTIONS

T O T A L H I P A R T H R O P L A S T Y S O L U T I O N S

Page 2: TOTAL HIP ARTHROPLASTY SOLUTIONS

AT DJO®, we’re pioneering technologies that challenge

the status quo with the intention of increasing performance for you and your patients. We strive to exceed your

expectations and exceed your needsas the market evolves. Our portfolios

are Different by Design, and we invite you to explore our comprehensive

Total Hip Arthroplasty portfolio in this brochure.

Greetings,

We look forward to working with you!

DJO’s hip ecosystem has at its core, products that are designed for any total hip procedure, created in collaboration with surgeons, utilizing relevant orthopaedic insights and trends, all supported by a well-trained salesforce. You’ll have the opportunity to learn about the anthropometric data we use in the research and development phase of an implant’s lifecycle, the clinical data on our proprietary ingrowth coating, as well as the surgical arm we’ve introduced to help reduce the number of assistants in the OR and put control back in your hands.

Our implant and instrumentation designs are supported by medical education programs that are tailored to your needs. [email protected] can be contacted for a full list of upcoming personalized educational opportunities.

Page 3: TOTAL HIP ARTHROPLASTY SOLUTIONS

EMPOWR Acetabular™ System

EXPRT®

Modular WagnerRevision Stem

TAPERFILL®

Tri-Taper™ Stem

HemiArthroplasty

Offerings

ADAPTABLE™

Leg and Retractor holder

REVEL ATION® microMA X ™

Anatomic StemLINEAR®

Wedge Stem

ORIGIN™

Compaction Broaching StemEVOLVE™

Cemented Stem

Page 4: TOTAL HIP ARTHROPLASTY SOLUTIONS

EMPOWR Acetabular™ SystemEMPOWR Acetabular™ is DJO’s modern, premium, intelligently designed acetabular system featuring advanced fixation technologies, efficient instrumentation, and a feature enabling future dual mobility offering.1 This system —combined with our femoral stem options which all have 12/14 robust micro-threaded trunnions—provides surgeons a comprehensive THA solution for all surgical approaches and settings

Anatomically Optimized Design Created using a virtual patient pelvic model derived from over a hundred CT scans, and analyzing bone thickness using a heat-map analysis (Red=Thick Bone; Green=Thin Bone). Insights from these analyses were leveraged to strategically place screw holes in the pelvic region with the thickest amount of bone to aid in maximal bone purchase.6

P2™ Coating Proprietary Titanium Porous coating by DJO Surgical®, is the first porous coating in the world wherein the non-spherical bead itself is also porous—giving it it’s name, P²™. This coating is proven to show disappearance of zone 2 radiolucent lines at one year follow up signifying osseointegration.2 Efficient Instrumentation EMPOWR Acetabular™ System has the ability to be implanted with just ONE TRAY resulting in as much as 50% in space and sterilization cost savings compared to some systems in the market.3 Instrument efficiency makes this system ASC ready for surgeons seeking cost minimization opportunities. Enhanced Screw Impants & Instruments Screw features allow for 24° angulation and screw geometry ensures flush seating4. The instrumentation has the ability to access tighter space and advance drill bit easily with reduced chances of tissue damage at the incision5.

Bone thickness analysis using CT scans(Red - Thick Bone; Green - Thin Bone)

Optimized hole placement design

Advanced Liner Locking Mechanism Definitive visual and tactile confirmation of fully seated condition (see Figure 1). Locking features have been extensively tested7 to establish correct tolerances without compromising on the poly thickness (Poly Thickness at the dome: 5.3mm)

HXe+™ Liners Highly-crosslinked, designed for ball and socket kinematics, and are blended with vitamin E (see Figure 1). In lab testing, these poly bearings have been demonstrated to significantly reduce oxidation and long-term wear.8

24°

Figure 1

Page 5: TOTAL HIP ARTHROPLASTY SOLUTIONS

TaperFill® StemTaperFill® is the first anatomically congruent, tri-taper stem designed from anthropometric data for improved stability.9 With instruments designed for the DAA and stem features such as a reduced lateral shoulder, curved distal tip and proprietary P2™ ingrowth coating, TaperFill® has been a preferred stem of choice by DAA surgeons since its introduction.

Proximal AP Taper A 12⁰ proximal taper (1) is designed to provide fixation and rotational stability through increased surface area contact with cortical bone structures.

Reduced Distal Taper A 4⁰ distal taper (2) is designed to reduce the possibility of stress shielding and helps account for proximal/distal mismatch.

ML Taper The ML taper (3) of the TaperFill stem is identical to DJO’s Linear® Hip stem which has demonstrated over 20 years of clinical history.

Standard and Lateral Offsets Direct lateralization of the neck allows for increased soft tissue tension without increasing leg-length.

Anthropomorphic data, constructed from CT scans, were used to determine the stem design.9

8mm

Reduced neck geometry designed for increased ROM

Reduced lateral shoulder for ease

of insertion.

EasyLead™ Distal Tipprotects bone and facilitates

final positioning

1

Proximal AP taper for enhanced stability

2

Reduced Distal taper to avoid stress shielding

Clinically successful ML taper geometry

20+ year clinical history

3

12°

8mm 45.1 49.1

20.4

2.8 2.8

-1σ

+1σ

μ

21.2

27.5 26.5

2.7

Page 6: TOTAL HIP ARTHROPLASTY SOLUTIONS

Origin™ StemA hydroxyapatite (HA) coated cementless implant with compaction broaching system and a streamlined instrument set. The design of this stem is based on the clinically successful principles of the CORAIL® system that has been successfully utilized in the US for over 30 years, implanted in over 2 million patients.10

Versatile

Three Collared Offset Options in one system to restore biomechanics. 135⁰ Collared and Non-Collared in Standard and Lateral offsets as well as a Collared Coxa Vera option with a 125⁰ neck angle.

Compaction Broaching Philosophy Created with the intent of preserving more blood supply compared to traditional rasping. Based on the clinically successful geometry, material and compaction broaching technique originated by the ATROS Group.10

Hydroxyapatite Coating (HA Coated Ti6Al4V) designed to promote osseointegration and stability.

Clinical DataIn a recent Journal of Arthroplasty study, Origin™ had “statistically significant lower postoperative periprosthetic fracture rate than TaperLoc®” with an experienced surgeon over a two year period following a transition to the Origin stem system.11

Page 7: TOTAL HIP ARTHROPLASTY SOLUTIONS

Reduced Proximal Lateral DesignThe proximal lateral shoulder of the Linear hip is reduced, which helps facilitate the implantation of the stem and helps to avoid varus implant positioning.

Linear® StemThe Linear® is a versatile hip system with a 20+ year clinical history that incorporates a reduced lateral shoulder, proximal fixation, and reduced distal geometry designed to provide a stable implant for multiple surgical approaches.

P2™ Fixation TechnologyMetaphyseal fit with rotational stability is key to the survivorship of flat wedge stems.12 Linear’s design includes a 6° proximal taper in addition to P2™ porous coating designed to provide a locking, proximal fit.

P2 Coating - 50x

Page 8: TOTAL HIP ARTHROPLASTY SOLUTIONS

EXPRT® Revision StemA premium, streamlined implant at a reinvented price point.A full-line, modular femoral stem inspired by the clinical success of Wagner style predecessors. The system’s intuitive design and premium quality is based on extensive research13 and development that redefines revision arthroplasty by offering an anatomically-inspired design that has an emphasis on efficiency and strength.

Case Study Gregory Polkowski, M.D. Vanderbilt UniversityRevision Cause:• Complex primary total hip for chronic femoral

neck fracture nonunion.

EXPRT® Revision Hip benefits in this case:• Variable body height allowed fine tuning.• Being able to dial in femoral anteversion

was key.• Short stem (130mm) was helpful in preserving

more bone.

DJO Surgical Exprt®

Zimmer-Biomet Arcos®

Stryker Restoration®

Impact at high speed creates a dimple

Stretched Surface

Compression

Efficiency and What it Means for You:EXPRT Revision Hip is a 2 tray revision system resulting in an 80-90% reduction in instruments compared to competitive systems.14,15 Streamlined instrumentation means less money and time spent on sterilization, less overall time in the operating suite, and less storage space.

An Emphasis on StrengthEXPRT Revision Hip tapers are shot peened, larger than competitors’ tapers,15,16 and can withstand fatigue loading without failure at 1,000 lbf for 5 million cycles with the worst case construct.17,18

Page 9: TOTAL HIP ARTHROPLASTY SOLUTIONS

EVOLVE™ StemProven Design.The Evolve™ stem is a highly polished, High Nitrogen Stainless Steel (ISO5832-9) dual tapered cemented stem based on the clinically successful design principals originated in Exeter, UK.19-22

This geometry creates compressive radial loading, designed to reduce friction between the cement and implant.

VersatilePrimary, Fracture, and Revision capabilities within one system. The collarless neck helps to facilitate intraoperative adjustments and four offset options to restore biomechanics, allowing independent fine adjustments of leg length, offset, and femoral fill.

LegacyA study in Clinical Orthopaedics and Related Research looked at the differences between the two methods of fixation in the +75yrs patient category.23 Early revision was 9.14 times more common in the best three cementless stems than in the best three cemented stems. The Evolve System honors the design classification similar to the best three performing cemented stems in this study.

Cu

mu

lati

ve P

erce

nt

Rev

isio

n

Years Since Primary Procedure

12%

10%

8%

6%

4%

2%

0%0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

BEST 3 CEMENTLESS FEMORAL STEMS VS BEST 3 CEMENTED FEMORAL STEMS

HR - adjusted for age and gender

0 - 1Mth: HR=8.82 (5.08, 15.31)vp<0.001

1Mth - 3Mth: HR=3.31 (1.39, 7.90)vp=0.006

3Mth + HR=1.13 (0.82, 1.57)vp=0.450

Best 3 Cementless Femoral Stems

Best 3 Cemented Femoral Stems

Page 10: TOTAL HIP ARTHROPLASTY SOLUTIONS

This stem geometry is based on a more complete understanding of hip joint biomechanics and bone morphology. MicroMAX’s lateral flare geometry is developed to mimic physiologic distribution of biomechanical loads by loading both lateral and medial cortices.24

StabilityDesigned to fit the metaphyseal area closely to maximize stability and provide physiologic load transfer and resulting stability.24

Anatomic Design The lateral flare, anterior prominence and flat posterior face engage the cortical walls of the inter-trochanteric region to combat subsidence and resist de-stabilizing forces in multiple planes.24

“This would create an internal collar which would provide the means to transfer load to the entire proximal perimeter of the femur (Gruen zones 1 and 7). As such the component could rest on the entire femur, distributing load both medially and laterally in a more physiologic fashion”24 (rest fit vs. press fit).

Advances in Orthopedics Volume 2019, Article ID 5804642“Unlike prior stem designs which demonstrate stress shielding, diaphyseal hypertrophy, thigh pain, subsidence, and occasional fracture on insertion, the ‘lateral flare’ stem design has minimized these adverse outcomes. Lateral flare stems have demonstrated preservation of >95% bone stock in proximal Gruen zones 1 and 7; less than 0.5 mm subsidence; no fracture on insertion of the stem when employing a ‘rest fit’ rather than press fit insertion technique; and no thigh pain.”24-28

2-year stress distribution within the femur as a consequence of stem design20

Revelation® microMAX™ Stem

press fit rest fit

Press fit vs. Rest fit

Page 11: TOTAL HIP ARTHROPLASTY SOLUTIONS

DJO® and a New Era for the DAA

Personalized training tailored to your needs featuring hands-on cadaveric opportunities with experienced DAA Faculty. Contact [email protected] for upcoming training opportunities.

Medical Education

DAA Friendly ImplantsWith a wide variety of DAA friendly stem implant designs, DJO has many options that can be utilized through a minimally invasive incision.

DJO’s DAA specific retractors feature:• Dual Curves to help reduce compression forces on

the soft tissue while maximizing the wound opening.

• Deep working ends to accommodate patients with increased BMI.

• Length to keep hands out of the operating area.

• Holes at the end of retractors to combine with the ADAPTABLE retractor holder.

The Direct Anterior Approach has been the fastest growing THA approach for more than the last decade.29 DJO® has stayed ahead of the curve by developing training, tools, implants, and instrumentation with the DAA in mind.

The first fully sterile, surgeon-controlled leg and retractor holder designed for a safe DAA.

ADAPTABLE™ DAA Specific Instrumentation

Page 12: TOTAL HIP ARTHROPLASTY SOLUTIONS

A Mobile Solution• Fully mechanical, lightweight, with a sleek carbon

fiber design.

• Easy to setup, transport, and store.

• A fraction of the size of a traditional specialty table.

A Versatile Platform• Optimized for the outpatient setting.

• A 2-in-1 efficient DAA Solution facilitating retractor placement and leg positioning for acetabular and femoral exposure.

• This allows the surgeon to perform a manual leg length assessment, as well as range of motion and impingement checks.

Gives You Total Control• The first fully sterile, surgeon-controlled leg

and retractor holder designed for a safe DAA.

• Helps decrease risks associated with undertrained or unauthorized staff running the specialty table.

• Can improve OR economy by better utilizing existing staff in the OR.

• Opportunity for a solo-DAA™ by optimizing OR headcount.

Page 13: TOTAL HIP ARTHROPLASTY SOLUTIONS

1 Pipeline product currently under development. Not available for sale.

2 Zielinski, et al. The Fate of Zone 2 Radiolucencies in Contemporary Highly-Porous Acetabular Components: Not All Designs Perform Equally. Presented on Friday, November 3, 2017 at the AAHKS Annual Meeting. https://aahks.scientificposters.com/epsAbstractAAHKS.cfm?id=2

3 Based on calculation of no. of trays compared to Pinnacle and G7. https://www.ajog.org/article/S0002-9378(16)30358-1/pdf for cost of sterilization.

4 Data on file at DJO® – PR18-033-01 Rev A. Aug 2018.

5 As compared to instrumentation in FMP system, with flexible shaft driver (803-05-239) and non-bowed drill guide (803-05-005). Data on file at DJO® - PR18-033-01 (9Nov2018)

6 Shallenberg, A. “STATISTICAL SHAPE MODEL OF THE PELVIS TO DRIVE SECONDARY INITIAL ACETABULAR FIXATION DESIGN.” Orthopaedic Proceedings. Vol. 101. No. SUPP_5. The British Editorial Society of Bone & Joint Surgery, 2019.

7 Data on file at DJO® – PR19-008-01Rev B. Aug 2019

8 Data on file at DJO Global. Laboratory testing does not necessarily indicate clinical performance.

9 TaperFill® White Paper (2014). DJO Literature 0021228-131 rev A 5/14.

10 Based on DePuy Corail System: http://www.corailpinnacle.net/sites/default/files/2019-03/102081-190116%20CORAIL%20Clinical%20Summary.pdf

11 Christensen, Katherine S., et al. “Prevalence of Postoperative Periprosthetic Femur Fractures Between Two Different Femoral Component Designs Used in Direct Anterior Total Hip Arthroplasty.” The Journal of arthroplasty (2019).

12 McLaughlin, Jeffrey R., and Kyla R. Lee. “Total hip arthroplasty with an uncemented femoral component: excellent results at ten-year follow-up.” The Journal of bone and joint surgery. British volume 79.6 (1997): 900-907.

13 Data on file at DJO Global. Laboratory testing does not necessarily indicate clinical performance.

14 http://www.zimmer.com/content/dam/zimmer-web/documents/en-US/pdf/surgica... – Accessed February 2017. 400+ Instrument SKUs in the ZMR Set compared to 39 for EXPRT® Revision Hip.

15 http://www.biomet.com/wps/wcm/connect/internet/c99ee315-9006-4509-9dc3-9... Accessed February 2017. 200+ Instrument SKUs in the Arcos Set compared to 39 for EXPRT Revision Hip.

16 http://www.rpa.spot.pt/getdoc/f9b4d81d-6b34-4d22-a374-d90299143771/RESTORATION-MODULAR-Surgical-Technique-(Stryker).aspx accessed September 2019

17 Data on file at DJO® – PR16-062-01 Rev. F Dec 2016

18 Data on file at DJO – PR17-035-01 Rev. A May 2017

19 Exeter® is a registered trademark of Stryker®

20 Ling, Robin SM, et al. “The long-term results of the original Exeter polished cemented femoral component: a follow-up report.” The Journal of arthroplasty 24.4 (2009): 511-517.

21 Petheram, T. G., et al. “The Exeter Universal cemented femoral stem at 20 to 25 years: A report of 382 hips.” The bone & joint journal 98.11 (2016): 1441-1449.

22 Schmitz, M. W. J. L., et al. “Results of the cemented Exeter femoral component in patients under the age of 40: an update at ten to 20 years’ follow-up.” The bone & joint journal 99.2 (2017): 192-198.

23 Tanzer, Michael, et al. “Is cemented or cementless femoral stem fixation more durable in patients older than 75 years of age? A comparison of the best-performing stems.” Clinical Orthopaedics and Related Research® 476.7 (2018): 1428-1437.

24 Fetto, Joseph F. “A Dynamic Model of Hip Joint Biomechanics: The Contribution of Soft Tissues.” Advances in Orthopedics 2019 (2019).

25 Leali, Alex, et al. “The effect of a lateral flare feature on implant stability.” International orthopaedics 26.3 (2002): 166-169.

26 Leali, Alex, and Joseph F. Fetto. “Preservation of femoral bone mass after total hip replacements with a lateral flare stem.” International orthopaedics 28.3 (2004): 151-154.

27 Leali, Alex, and Joseph Fetto. “Promising mid-term results of total hip arthroplasties using an uncemented lateral-flare hip prosthesis: a clinical and radiographic study.” International orthopaedics 31.6 (2007): 845-849.

28 Leali, Alex, Joseph Fetto, and Harvey Insler. “Favorable midterm results of total hip arthroplasties with a lateral flare uncemented stem.” Clinical Orthopaedics and Related Research (1976-2007) 450 (2006): 138-144.

29 AAHKS survey 2018

Trademarks

BIOLOX delta® is a registered trademark of Ceramtec GMBH.

Corail®is a registered trademark of DePuy Synthes.

Taperloc® is a registered trademark of Zimmer Biomet. Inc.

Arcos® is a registered trademark of Biomet Manufacturing,

LLCRestoration® is a registered trademark of Howmedica Osteonics Corp

Origin™ and Evolve™ are trademarks of SIGNATURE ORTHOPAEDICS PTY LTD

References

Page 14: TOTAL HIP ARTHROPLASTY SOLUTIONS

Notes

Page 15: TOTAL HIP ARTHROPLASTY SOLUTIONS

Individual results may vary. DJO Surgical® is a manufacturer of orthopedic implants and does not practice medicine. Only an orthopedic surgeon can determine what treatment is appropriate. The contents of this document do not constitute medical, legal or any other type of professional advice. This material is intended for the sole use and benefit of the DJO Surgical sales force and physicians. It is not to be redistributed, duplicated or disclosed without the express written consent of DJO Surgical. For product information, including indications, contraindications, warnings, precautions and side effects, refer to the Instructions for Use supplied with the device.

T 800.456.8696 D 512.832.9500 F 512.834.63009800 Metric Blvd. I Austin, TX 78758 I U.S.A.DJOGlobal.com/surgical

Copyright © 2020 by DJO, LLCMKT0020201-003 Rev B