G7 acetabular SYSteMDesign rationale

G7 Des iGn Rat ionale

Surgeon DeveloperS

Simplicity. efficiency. performance.

the G7 acetabular System unites the latest technological developments in bearing design with a simple, elegant and

highly flexible instrumentation system designed to optimize the operating room experience. the system’s wide range of

acetabular shell, fixation and bearing options provides the power to personalize implant selection for each within a single

platform that delivers:

› Modern shell design features for

maximized performance

› Multiple clinically proven bearing

and fixation options

› Personalized instrumentation

system for increased

operating room efficiency

› Patent pending color-coded

implant and instrumentation

system for streamlined

surgical flow

› Dr. Mike berend center for Hip and Knee Surgery Mooresville, IN, uSa

› Professor thorsten Gehrke eNDO-Klinik Hamburg, Germany

› Professor Guido Grappiolo Humanitas clinical Institute rozzano Milano, Italy

› Dr. David liu Gold coast centre for bone and Joint Surgery Gold coast, australia

› Dr. William long the computer Surgical Institute los angeles, ca, uSa

› Professor eric Masterson university of limerick Medical School limerick, Ireland

› Dr. Michael Miller university Orthopedic Specialists tucson, aZ, uSa

› Dr. rafael Sierra rochester, MN, uSa

› Dr. Matthew Squire university of Wisconsin Orthopedics Madison, WI, uSa

› Professor Nobuhiko Sugano Osaka university Osaka, Japan

Patient-SPecific mini tRaySinStrument Wave trayS

boneMaster limited Hole

Freedom constrained liner

biolox® delta ceramic Head

biolox® delta Option ceramic Head

cocr Head Freedom constrained cocr Head

Sizes 28-36 mm ce marked

Sizes 28-40 mm ce marked

Neutral liner

High Wall liner

10 Degree liner

Neutral liner

High Wall liner

10 Degree liner

liner

acetabular ShellS

ceramic linerS

femoral heaDS

e1 antioxidant arcomXlpolyethylene linerS

biolox® delta

efficiency doesn’t demand the elimination of options. the G7 System allows surgeons and hospitals

to provide the optimal implants for each patient while benefiting from the efficiency of a

streamlined delivery system.

SyStem overvieW

Sizes28-44 mm

Size32 mm and 36 mm

0102

PPS limited Hole

DesiGneD foR PeRfoRmance

Polyethylene and Hard bearing locking Mechanism accommodates multiple polyethylene configuration options and hard bearing surfaces where available

Pre-Plugged Screw Holes provide the operative flexibility to choose between a solid shell construct or adding screws for additional stability

the G7 dome loading design provides maximum liner support to minimize locking mechanism fatigue.

hemiSpherical DeSign the hemispherical design of the G7 acetabular

shell closely matches the shape of the natural

acetabulum, allowing for minimal removal of

bone while maximizing contact area between

the implant and bone.

50 mm

180°

DesiGneD foR PeRfoRmance

* Primary identification should be made using size and letter designations.

aDvanceD fixation oPtions

ppS porouS plaSma Spray: PPS Porous Plasma Spray has over

25 years of clinical history providing

primary implant fixation for the

biomet cementless portfolio.

using biocompatible titanium alloy

powder and proven plasma spray processing, PPS offers:

› High fatigue strength achieved by never heating

the substrate1

› Short- and long-term fixation gained from variable

pore size distribution2

› roughened scratch fit due to irregularly shaped particles2,3

bonemaSter: boneMaster is an advanced coating

technology designed to improve the

performance of cementless implants

by mimicking natural bone physiology.

With the biological benefits of

hydroxyapatite (Ha) and an enhanced

nano-structure based on apatite crystals

found in bone,4 boneMaster offers:

› enhanced implant stability by creating a favorable

environment for osteoblast adhesion

› roughness of PPS Porous Plasma Spray with 1/10th the

thickness of traditional Ha

› reduced fibrous ingrowth due to unique nano-structure

which mimics apatite found in bone, promoting

osteoconductivity and faster bone integration5-7

› Significantly greater bone density postoperatively compared

to identical plasma-sprayed Ha stems8,9

Shell configuration G7 shells are available in a

limited hole design with three

holes clustered near the apex of

the shell to allow for placement

of screws in the strongest part of

the pelvic bone. Screw holes are

pre-plugged to limit the migration

of polyethylene debris that could

potentially result in osteolysis and

provide an uninterrupted support

structure to reduce the possibility

creep of the polyethylene into open

screw holes. the plugs can be

removed if supplemental fixation

is desired.

Proprietary color-coded Shell corresponds with instrumentation and labels to create an efficient and accurate Or environment*

clinically Proven PPS Fixation has over 25 years of successful clinical history providing initial scratch-fit stability and excellent long-term fixation1-4

0304

beaR inG oPt ions

polyethylene materialSMeeting the modern demands of bearing surfaces means achieving the optimal balance of maximized strength, wear

resistance and oxidation resistance. biomet’s polyethylene bearings achieve this by pairing the latest technological

advancements with the strong heritage of clinically proven arcom polyethylene. the G7 system offers two

polyethylene materials for use with biolox® delta ceramic or cocr femoral heads.

e1 antioxidant Infused technology

e1 is the only antioxidant infused bearing technology

to use a proprietary diffusion process to maximize

strength, wear resistance and oxidative resistance via

the oxidative protection of vitamin e. Vitamin e actively

protects the bearing surface from the damaging effects

of oxidation over time.10 In addition, e1 acetabular liners

offer wear rates similar to hard-on-hard bearings when

paired with a ceramic head.1,11

arcomXl Highly crosslinked Polyethylene

arcomXl acetabular liners utilize a solid state

deformation process to obtain optimal wear resistance

without sacrificing mechanical strength or increasing

oxidation levels. arcomXl shows a 47% decrease in

volumetric wear rate when compared to a moderately

crosslinked polyethylene.1

CoCr on E1 Biolox® deltaon E1

55.0

50.0

45.0

40.0

35.0

30.0

25.0

20.0

15.0

10.0

5.0

0 3.36 2.82

Polyethylene WeaR9

5 million cycles on a hip simulator

Volu

met

ric W

ear

(mm

3 /m

illio

n C

ycle

s)

Biolox® deltaon ArComXL

12.8910.04

CoCr onArComXL

* Gamma Sterilized polyethylene test performed with 28 mm bearings. april, 2007

all other tests were performed with 62 mm acetabular shells and 44 mm bearings. Sept., 2012

*Gamma Sterilized Polyethylene 53.3 mm3

polyethylene profileS

10 Degree

Face changing

Freedom constrained

High Wall

Neutral

Designed to increase range of

motion, while decreasing the

possibility of impingement, by

means of an optimized chamfer

around the inner diameter of

the liner.

Offers 5mm material build

up (typically positioned in the

posterior superior quadrant) for

additional stability.

used to restore the center

of rotation and achieve more

joint stability when acetabular

components have been

vertically placed.

Designed to actively counter

the distractive forces that can

lead to recurrent hip dislocation.

utilizes a cobalt chrome head

with circumferential flats for

easier head reduction and a

constraining ring to supplement

the liner’s stability by increasing

resistance to lever-out forces.

0506

polyethylene liner thickneSS matrix

45°

apex

Minimum Poly Liner Thickness at 45° (mm)

Shell SizeHead Size

28 32 36 40 44

42 - A4.3

44 - A

46 - B 6.3 4.3

48 - C 7.3 5.3

50 - D 8.3 6.3 4.3

52 - E 9.3 7.3 5.3

54 - F10.3 8.3 6.3 4.3

56 - F

58 - G11.3 9.3 7.3 5.3

60 - G

62 - H11.3 9.3 7.3 5.3

64 - H

66 - I

11.3 9.3 7.368 - I

*70 - I

*72 - I

*74 - J

14.3 12.3 10.3*76 - J

*78 - J

*80 - J

*Not available in limited hole configuration

Minimum Poly Liner Thickness at Apex (mm)

Shell SizeHead Size

28 32 36 40 44

42 - A4.7

44 - A

46 - B 6.7 4.7

48 - C 7.7 5.7

50 - D 8.7 6.7 4.7

52 - E 9.7 7.7 5.7

54 - F10.7 8.7 6.7 4.7

56 - F

58 - G11.7 9.7 7.7 5.7

60 - G

62 - H11.7 9.7 7.7 5.7

64 - H

66 - I

11.7 9.7 7.768 - I

*70 - I

*72 - I

*74 - J

14.7 12.7 10.7*76 - J

*78 - J

*80 - J

*Not available in limited hole configuration

the G7 acetabular System offers biolox® delta ceramic

heads for ceramic on polyethylene articulations in 28, 32,

36, and 40 mm diameters. biolox® delta ceramic is a highly

biocompatible mixed oxide ceramic with high fracture

resistance and ultra low wear. constructed of 82% alumina,

17% zirconia and other trace elements, this third generation

ceramic is an alumina matrix composite that provides

increased fracture toughness and strength when compared

to traditional alumina ceramic.10

With over 1.6 million implanted worldwide, biolox® delta ball

heads offer a clinically successful high performance option.10

ceramic mater ial

1.6 millionover

implanteD WorlDWiDe10

polyethylene locking Strengththe G7 polyethylene locking feature maximizes

strength and minimizes micromotion by means

of a tightly toleranced tongue and groove fit

between the shell and the liner. While offering

high locking strength, the unique geometry of

the locking barb also requires minimal impaction

force to engage the liner into the shell, reducing

risk of shell malalignment.

Strength teSting:acetabular systems must be strong enough to withstand the loading conditions commonly seen in the hip,

maximizing strength and minimizing micromotion. liner push out, lever out, torque out and rim impingement are

industry accepted testing methods which measure the strength of both the locking mechanism and the liner.

G7 polyethylene and ceramic liners were subjected to push out, lever out and torque out testing under worst

case conditions.

lockinG mechanism stRenGth

harD bearing locking Strengththe hard bearing locking feature utilizes

a 10 degree conical taper as well as a

roughened finish to achieve maximum

surface contact with the liner, resulting in

a secure taper fit. an apical button on the

liner aids in alignment upon insertion but is

not a part of the locking mechanism.

0708

lever out Strength

60

50

40

30

20

10

0

2843% lower

50

2353% lower

Forc

e (N

m)

Strykertrident

X3 (10 Mrad)

DePuy SynthesPinnacle

altrX (7.5 Mrad)

biomet G7

e1 (10 Mrad)

51Statisticallyequivalent

Zimmercontinuum

longevity (10 Mrad)

Lever Out Strength11

lever Out: Disassembly force required to dislodge a polyethylene liner from an acetabular shell

all tests were performed with 54 mm acetabular shells and 32 mm acetabular liners

puSh out Strength

3000

2500

2000

1500

1000

500

0

22452061

8% lower

84762% lower

142036% lower

biomet G7

e1 (10 Mrad)

Forc

e (N

)

Strykertrident

X3 (10 Mrad)

DePuy SynthesPinnacle

altrX (7.5 Mrad)

Zimmercontinuum

longevity (10 Mrad)

Push Out Strength11

Push Out: axial force required to dislodge a polyethylene liner from an acetabular shell.

all tests were performed with 54 mm acetabular shells and 32 mm acetabular liners

Polyethylene results:

the average push out force of a G7 polyethylene acetabular liner is 2245 N.11

60 almoSt

timeS the minimum acceptance criteria11

liner puSh out: Push out testing measures the axial force required

to dislodge a polyethylene liner from an acetabular

shell. conducted per aStM F1820-97, an assembled

shell and liner was attached to a push-out fixture that

supported the cup without distortion. an axial load of

2 inches per minute was applied to the liner through

the apical hole of the shell.11

Similar to the G7 polyethylene testing regimen,

G7 ceramic liners were subjected to push out,

lever out and torque out testing. additional tests

were also conducted, specific to the ceramic liner.

Hard bearing results: the average push out force of a G7 acetabular ceramic liner is

11,590 N,1 almost 60 times the minimum acceptance criteria of 200 N, set by ceramtec,

the manufacturer of biolox® delta ceramic.1,12

liner lever out teSting:Measures the disassembly force required to dislodge a polyethylene liner from an acetabular shell. conducted per a published testing method,13 a metal lever arm was inserted into a slot cut into the liner (polyethylene) or a metal lever arm was inserted into a washer epoxyed into the liner (hard bearing) and loaded at 2 inches per minute until liner separation.

50 nm11

DiSaSSembly force requireD to DiSloDge a polyethylene liner from an acetabular Shell

Hard bearing results: the average lever out force of a G7 ceramic acetabular liner is 32 Nm.1

Polyethylene results: the average lever out force of a G7 polyethylene acetabular liner is 50 Nm.11

0910

liner torque out:Measures the disassembly force required to torque-out a liner from an acetabular shell. conducted per

documented test methods13,15 the shell and liner were inserted into a test fixture which applies torsional force

to the shell and liner. torsion was applied at a rate of 1 degree per second until the liner rotated 45 degrees

as noted by lines marked on the face of the shell and liner.

Hard bearing results: the average

torque-out force of a G7 ceramic acetabular

liner is 63 Nm. the maximum frictional torque

seen in-vivo at the femoral head to liner

interface is approximately 2.4 Nm.1,13,16

rim impingement: the ability of the acetabular liner to withstand possible rim impingement, or impaction of the rim of the liner

by the stem trunnion, is also key to the long term success of the implant. rim impingement loading can occur in-vivo

as a result of malalignment or patient movements that require a large range of motion.

conducted per aStM F2582, the trunnion of a stem was allowed to contact the rim of the liner at a joint reactive

force of 1000 N, simulating rim impingement loading conditions. Following the test, the liners were visually inspected

for signs of damage.

Polyethylene results:

Visual inspection of arcomXl and e1 liners showed

no cracking, pitting or gross damage to the inner and

outer region of the rim.1

Polyethylene results: the average torque-out

force of a G7 polyethylene acetabular liner is

29 Nm. the maximum frictional torque seen

in-vivo at the femoral head to liner interface is

approximately 2 Nm.11,13,16

1112

freeDom conStraineD liner lever out:liner lever out was also measured for the Freedom constrained acetabular liner. conducted per a

published testing method,15 load was applied to a femoral head with a lever arm attached at the rate of 2

inches per minute until the head or liner dislodged from the shell.

Freedom constrained liner results:

Shell/liner combinations, the average lever out force

of a G7 Freedom constrained acetabular liner is

18 Nm, although none of the constrained liners actually

levered out during the test. Per its designed intent, the

constrained femoral head dislodged before the liner in

all of the samples. this feature is designed to prevent

forces that might dislodge the fixation of the acetabular

shell in the case of a constrained liner.1

inSertion valiDation anD apical button burSt teSting Fracturing of a ceramic liner is the most

common complication in the rare instance

of ceramic failure. this fracture may

be caused by intraoperative chipping

that can occur when the ceramic liner

is not aligned properly in an acetabular

shell upon impaction or if the surgeon

forcibly tries to realign a malaligned liner.

For this reason, the G7 ceramic liner is

designed with an apical button to help

aid in alignment upon insertion. additional

testing validated this design feature.

Insertion Validation

a cadaveric validation study was

conducted to simulate intraoperative

insertion of a ceramic liner into an

acetabular shell. this demonstrates the

optimal performance of the G7 acetabular

System with regards to intraoperative liner

chipping. On separate occasions, two

practicing surgeons exposed the hip joint

while maintaining standard incision lengths

and soft tissue dissection and inserted 40

ceramic liners. In total 80 ceramic liners

were included in the validation study.1

results: During the cadaveric validation

study none of the ceramic liners chipped

when inserted into an acetabular shell that

had been impacted using a “line to line” or

“2 mm under” reaming technique.1

results: there was no significant difference between the

burst strength of the liners before and after fatigue testing.

examination of the fracture patterns before and after fatigue

of the liners showed that the liners failed with a spiraled

crack originating from the rim of the liner. the fracture pattern

of the liners does not show any interaction with the apical

feature, indicating that the novel geometry is not detrimental

to the strength or performance of the liner.1

80 ceramic linerS Were incluDeD in the valiDation StuDy.

apical button Fatigue burst

evaluates any impact of a novel apical button

feature on the burst strength of the ceramic

liner, under extreme loading conditions in

excess of any testing parameters prescribed

by national or international standards.

G7 acetabular shells were potted at a

60 degree inclination angle to simulate extreme

cup placement. ceramic liners were then

inserted and subjected to a 10 million cycle

fatigue test. Post fatigue testing, load was

applied until the liner burst.1

1314

Over 1 million times per year, biomet helps one surgeon provide personalized care to one patient.

the science and art of medical care is to provide the right solution for each individual patient. this requires clinical mastery, a human connection between the surgeon and the patient, and the right tools for each situation.

at biomet, we strive to view our work through the eyes of one surgeon and one patient. We treat every solution we provide as if it’s meant for a family member.

Our approach to innovation creates real solutions that assist each surgeon in the delivery of durable personalized care to each patient, whether that solution requires a minimally invasive surgical technique, advanced biomaterials or a patient-matched implant.

When one surgeon connects with one patient to provide personalized care, the promise of medicine is fulfilled.

this publication and all content, is protected by copyright, trademarks and other intellectual property rights owned by or licensed to biomet Inc. or its affiliates unless otherwise indicated. It must not be used, copied or reproduced in whole or in part without the express written consent of biomet or its authorized representatives.

biolox® delta is a trademark of ceramtec.

this material is intended for the physicians and the biomet sales force only. the distribution to any other recipient is prohibited.

check for local product clearances and reference product specific instructions for use.

For product information see package insert and biomet’s website.

Material not approved for use or distribution in France.

One Surgeon. One Patient.

References

1. Data on file at biomet. bench test results not necessarily indicative of clinical performance.

2. Market, D.c. et al. Initial Scratch Fit Stability of acetabular cups: comparison of three Porous coating Systems. ISta. San Diego, ca. 1997.

3. andersson, l. et al. Immediate or late Weight bearing after uncemented total Hip arthroplasty. Journal of Arthroplasty. 16(8): 1063-65, 2001.

4. robler S,. et al. electrochemically assisted deposition of thin calcium phosphate coating at near-physiological pH and temperature. Journal of Biomedical Materials Research. 64a:655-663. 2003.

5. Mont Ma. et al. Proximally coated Ingrowth Prosthesis. a review. Clinical Orthopedics 344: 139-149. 1997.

6. emerson r., et al. effect of circumferential plasma-spray porous coating on the rate of femoral osteolysis after total hip arthroplasty. The Journal of Bone and Joint Surgery. 81: 1291-1298. 1999.

7. bourne r., et al. Ingrowth surfaces: Plasma spray coating to titanium alloy hip replacements. Clinical Orthopedics Related Research 298: 37-46. 1994.

8. Schliephake H., et al. biomimetic calcium phosphate composite coating of dental implants, International Journal of Oral Maxillofacial Implants: 21 (5):738-46. 2006.

9. Schliephake H., et al. biological performance of biomimetic calcium phosphate coating of titanium implants in the mandible a pilot study in dogs, Journal of Biomedical Material Research. 64a: 225-234. 2003.

10. uS FDa cleared claim. See biomet.com/e1 for complete claim language.

11. Study conducted by biomet with independent lab. laboratory testing august, 2013. test results are not necessarily indicative of clinical performance.

12. Data on file at ceramtec GmbH.

13. FDa draft guidance: testing of acetabular prosthesis

14. tradonsky, S., et al. Performance characteristics of two Piece acetabular cups Series II. Scientific exhibit. 62nd annual aaOS Meeting. 1996.

15. Haft, G., et al. a biomechanical analysis of Polyethylene liner cementation into a Fixed Metal acetabular Shell. The Journal of Bone and Joint Surgery, 85-a: Number 6, June 2003.

16. Marlowe, D., et al. Modularity of Orthopedic Implants. Issue 1301. aStM International, January 1997.

One Surgeon. One Patient.

ORTHOPEDICSSM

©2013 biomet Orthopedics • Form No. bMet0756.0-INt • reV0913

Legal Manufacturerbiomet Orthopedics P.O. box 58756 e. bell DriveWarsaw, Indiana 46581-0587 uSa

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Note: For ceramic components contained within this Surgical technique biomet uK, ltd is the legal Manufacturer.

www.biomet.com

0086

European Representativebiomet uK, ltd.Waterton Industrial estatebridgend, South WalescF31 3Xa uK