NORIAN® DRILLABLEFiber reinforced calcium phosphate bone void fi ller

NORIANNORIAN® DRILLABLEFiber reinforced calcium Fiber reinforced calcium phosphate bone void fi llerphosphate bone void fi ller

TECHNICAL MONOGRAPH

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IndicationsNorian Drillable is intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void fi ller that resorbs and is replaced with bone during the healing process. Norian Drillable can be used as an adjunct to conventional rigid hardware fi xation by supporting the bone fragments during the surgical procedure. Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. Norian Drillable is intended to be placed into bony voids either before or after fi nal fi xation.

ContraindicationsThe safety and effectiveness of this device for use in the spine has not been established.Use of this device is contraindicated in the spine, including use in the pedicle, as this could be associated with leakage of the device material into the bloodstream, which could cause serious adverse events, including death.Norian Drillable should not be used in the presence of active or suspected infection.

Norian Drillable is not for screw augmentation.

Norian Drillable is not for use in:• Patients with traumatic open injuries that are predisposed to

infection• Stress-bearing applications• Areas where adjacent bone is avascular, or is incapable of

supporting or anchoring the implanted rigid fi xation hardware• Patients with compromised health (e.g. abnormal calcium

metabolism, metabolic bone disease, a recent local untreated infection, vascular or severe neurological disease, infection, immunologic defi ciencies or systemic disorders) that result in poor wound healing or will result in tissue deterioration over the implant site

• Patients who are skeletally immature• Vertebral compression fractures• Intra-articular space (i.e., material injected into the joint space)

Please refer to the instructions for use for a complete list of indications, contraindications, warnings, and precautions.

INDICATIONS & CONTRAINDICATIONS

Norian® Drillable

Norian Drillable is intended for bony voids ordefects of the extremities and pelvis that are not intrinsic to the stability of the bony structure.

Norian® Drillable

*Toughness is defined as a measure of a material’s resistance to fracture when stressed. Data on file with DePuy Synthes.

INTRODuCTION

Bioresorbable FibersBioresorbable poly(lactide co-glycolide) (PLGA) fibers are uniformly distributed and randomly oriented within the material. These fibers provide added toughness, which reduces crack propagation and allows for the material to be drilled and tapped.

Calcium Phosphate Powder The calcium phosphate powder that makes up Norian Drillable converts in vivo to form carbonated apatite, closely resembling the mineral phase of bone. It is gradually resorbed and replaced with bone during the natural bone healing process. Calcium phosphate has been widely used in clinical applications for decades, resulting in the availability of many publications and clinical cases demonstrating its safety and efficacy to address bone regeneration.1

Sodium Hyaluronate The liquid component is a pH-neutral solution that increases viscosity, leading to improved mixing and handling.

Key Components

1 Bajammal S, Zlowodzki M, Lelwica A, et al. The use of Calcium Phosphate Bone Cement in Fracture Treatment. A Meta-Analysis of Randomized Trials. J Bone Joint Surg Am. 2008 Jun;90(6):1186-96.

Norian Drillable is a biocompatible, fiber reinforced, calcium phosphate, bone void filler that can be implanted either before or after final fixation, allowing flexibility of application.

The reinforcing fibers enhance the material’s structural integrity by providing added material toughness,* allowing for drillability, and increasing the material’s resistance to cracking. Due to its unique material composition, when set, it closely resembles the mineral phase of bone and is gradually resorbed and replaced with bone during the natural bone healing process.

2. Constantz B, Ison IC, Fulmer MT, et al. Skeletal repair by in situ formation of the mineral phase of bone. 1995;267(5205):1796-9.

Norian Drillable

Bone

Sintered Hydroxyapatite

Coral-Derived Hydroxyapatite

2 THETA

CN

TS/S

EC

Figure 1. Crystallographic analysis by Powder X-ray Diffraction (XRD)

Once Norian Drillable is fully set, the resulting biomaterial formed is carbonated apatite which has a crystallographic characteristic and chemical composition similar to bone, as demonstrated in Figure 1.

Although hydroxyapatite is commonly thought of as the mineral phase of bone, carbonated apatite actually constitutes 60–70% of total dry bone weight. The main distinction between hydroxyapatite and carbonated apatite is the presence of carbonate. Hydroxyapatite does not contain any carbonate, however the carbonate content of Norian Drillable is approximately 4.5%, which more closely resembles the mineral phase of bone, 4–6% (Figure 2).

SIMILAR TO BONE

Norian Drillable hardens in vivo to form carbonated apatite, closely resembling the mineral phase of bone.

Norian Characteristic Bone2 Drillable

Carbonate content 4.0 –6.0% 4.5%

Ca/P molar ratio 1.33 –1.73 1.60 Crystal order Low Low

Perfect crystal size ~200 Å ~200 Å Chemical make-up Inorganic/ Inorganic/ organic organic

Figure 2. Properties of Bone vs. Norian Drillable

*Mechanical test results are not necessarily indicative of clinical performance.

For ergonomic reasons, the amount of load required to inject material from a syringe should be minimized as elevated injection forces may make it difficult to successfully implant the biomaterial.

Figure 3. Injection Test*Norian Drillable, Norian SRS®, and Stryker® Hydroset™

One of the distinguishing features of Norian Drillable is that it sets in a moist environment. A warm, wet environment ensures that the material can fully convert to carbonated apatite. In contrast, if the material is exposed to a dry environment during the setting process, it would become brittle and chalky. Therefore, in order to set properly and attain full compressive strength, Norian Drillable requires a wet, 37°C environment.

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HydroSet

Peak

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f)SETS IN A WARM, WET ENvIRONMENT

EASIER TO INJECT

A TOuGHER MATERIAL

Three Point Bend TestA three point bend test measures the flexural strength of a material. From the flexural test, the material’s toughness can also be established. Work of fracture is a quantitative way of expressing a material’s toughness, or the ability of a material to resist crack propagation. To determine the work of fracture, a stress-strain curve is generated during the three point bend test. From this curve, the material’s toughness or work of fracture is calculated.

Norian Drillable has a higher average work of fracture compared to Norian SRS and Hydroset, as demonstrated by the results of the three point bend test (Figure 4). This difference is directly related to the toughness of the material, as graphically shown by the stress-strain curve (Figure 5).

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k of

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ctur

e (J

/m2 )

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Figure 4. Three Point Bend Test*

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ss (M

Pa)

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Figure 5. Comparison of Material Toughness

*Mechanical test results are not necessarily indicative of clinical performance.

Reinforcing fibers increase the material’s toughness.

Ceramic materials are brittle in flexural

loading. However, the incorporation of

bioresorbable fibers in Norian Drillable

increases its material toughness compared

to other ceramics. It is the addition of these

fibers that provides improved handling and

resistance to cracking as well as allows the

material to be drilled, tapped and screws

placed through it at any time during or

after the setting process.

REINFORCING FIBERS

Norian Drillable’s reinforcing fibers are present during the setting process to allow for drilling. Over time, these reinforcing fibers begin to degrade through hydrolysis. To demonstrate the relationship between the fiber degradation and the material’s work of fracture, three point bend tests were conducted at time points throughout the course of a year on samples that experienced simulated body conditions. The testing verified that Norian Drillable has an increased toughness over a period of several months. As the reinforcing fibers degrade, the material toughness of Norian Drillable reduces to levels comparable to Norian SRS.

Figure 6. Norian Drillable Fast Set PuttyWork of Fracture Degradation In Vitro

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k of

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ctur

e (J

/m2)

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Figure 7. Norian Drillable InjectWork of Fracture Degradation In Vitro

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Norian Drillable

COMPRESSIvE STRENGTH

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0Norian Drillable FSP

Norian Drillable Inject

Com

p. S

tres

s (M

Pa)

Norian SRSFSP

Norian SRSRotary Mix

HydroSet

As Norian Drillable sets, it begins to form carbonated apatite. The micro-structural development occurs as bridges form between adjacent particles. The scanning electron microscope (SEM) images on the adjacent page illustrate the structure of the material as it sets. As the carbonated apatite is formed, the compressive strength of the material increases. At 24 hours, the Norian Drillable Inject has reached its maximum compressive strength of approximately 35 MPa, which is greater than that of cancellous bone.3

Figure 8. Compression Test*

*Mechanical test results are not necessarily indicative of clinical performance.

3. Cowin, SC ed. Bone Mechanics Handbook. 2nd ed. New York, NY: CRC Press, 2001. 16-3. Print.

Norian Drillable reaches maximum compressive strength in approximately

24 hours.

Compressive Strength

Start of Mix Post Mix 10 minutes at 37˚C 24 hours

Figure 8. Norian Drillable Microstructural Development (SEM Images)

Norian Drillable Norian SRS Cancellous BoneCompressive Strength Inject: ~35MPa Inject: ~50MPa ~5–7MPa3

FSP: ~25MPa FSP: ~30MPa

Norian Drillable Fast Set Putty, sterile07.704.103S 3 cc07.704.105S 5 cc07.704.110S 10 cc

Norian Drillable Inject, sterile07.704.003S 3 cc07.704.005S 5 cc07.704.010S 10 cc

Also Available

Delivery Needles, sterile

Single Pack 5 Pack

DLS-7083-01S DLS-7083-05S 8 gauge x 10 cm

DLS-7103-01S DLS-7103-05S 10 gauge x 10 cm

n/a DLS-7121-05S 12 gauge x 5 cm

DLS-7122-01S DLS-7122-05S 12 gauge x 7.5 cm

DLS-7123-01S DLS-7123-05S 12 gauge x 10 cm

n/a DLS-7124-05S 12 gauge x 12.5 cm

DLS-7126-01S DLS-7126-05S 12 gauge x 10 cm, curved

MXR-uS-2000 Rotary Mixer

PRODuCT INFORMATION

DePuy Synthes Biomaterials1302 Wrights Lane EastWest Chester, PA 19380 Telephone: (610) 719-5000 To order: (800) 523-0322

www.depuysynthes.com

© DePuy Synthes Biomaterials, a division of DOI 2014. All rights reserved.J11469-B 4/14 Norian and SRS are trademarks of DSM Biomedical or its affiliated. Competitive trademarks are the property of the associated company or its affiliates.

Limited Warranty and Disclaimer: DePuy Synthes Biomaterials products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed.

WARNING: In the USA, this product has labeling limitations. See package insert for complete information.

CAUTION: USA law restricts these devices to sale by or on the order of a physician.

Not all products are currently available in all markets.

Synthes (Canada) Ltd. 2566 Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) 567-0440 To order: (800) 668-1119 Fax: (905) 567-3185