RAPIDSORB® RAPID RESORBABLE FIxATION SySTEmFor craniofacial reconstruction

PRODUCT OVERVIEW

BleedCrop

For craniofacial reconstruction

RAPIDSORB Rapid Resorbable Fixation System DePuy Synthes Companies 1

RAPIDSORB RAPID RESORBABLE FIxATION SySTEm

FeaturesRapid resorbable implants maintain appropriate fixation for bone healing for approximately 8 weeks postoperatively.1

x Resorbs in approximately 12 months1 x Degrades without late inflammatory complications and

foreign-body responses that have been observed with semicrystalline structures such as poly (L-lactide)2,3

x Eliminates concerns for potential migration and translocation associated with metallic implants4,5

x Eliminates secondary surgeries for implant removalx Proven biocompatible material6

x Radiolucent polymer does not interfere with intraoperative or postoperative radiographs7,8

x Polymer strength is not affected by radiation therapy9,10

x Full line of instrumentation and customizable trays

References: 1. Average strength retention data on file at DePuy Synthes Companies of

Johnson & Johnson.2. Bergsma JE, de Bruijn WC, Rozema FR, et al. Late degradation tissue response

to poly(L-lactide) bone plates and screws. Biomaterials. 1995;16(1):25-31.3. Böstman Om, Pihlajamäki HK. Late foreign-body reaction to an intraosseous

bioabsorbable polylactic acid screw. A case report. J Bone Joint Surg Am. 1998;80(12):1791-4.

4. yu JC, Bartlett SP, Goldberg DS, et al. An experimental study of the effects of craniofacial growth on the long-term positional stability of microfixation. J Craniofac Surg. 1996;7(1):64-8.

5. Stelnicki EJ, Hoffman W. Intracranial migration of microplates versus wires in neonatal pigs after frontal advancement. J Craniofac Surg. 1998;9(1):60-4.

6. Based on biocompatibility testing per ISO10993-1:1997(E) conducted by Synthes USA.

7. Rikli DA, Regazzoni P, Perren Sm. Is there a need for resorbable implants or bone substitutes? Injury. 2002;33(Suppl 2):B2-3.

8. Rovinsky D, Durkin RC, Otsuka Ny. The use of bioabsorbables in the treatment of children’s fractures. Tech in Ortho. 1998;13:1–9.

9. mohiuddin m, Fujita m, Regine WF, et al. High-dose spatially-fractionated radiation (GRID): a new paradigm in the management of advanced cancers. Int J Radiat Oncol Biol Phys. 1999;45(3):721-7.

10. Rozema FR, Levendag PC, Bos RR, et al. Influence of resorbable poly(L-lactide) bone plates and screws on the dose distributions of radiotherapy beams. Int J Oral Maxillofac Surg. 1990;19(6):374-6.

100% strength at implantation 95% strength at 4 weeks1

85% strength at 8 weeks1 Resorption in 12 months1

2 DePuy Synthes Companies RAPIDSORB Rapid Resorbable Fixation System

Basic ScienceThe implants of the RAPIDSORB® Rapid Resorbable Fixation System are manufactured from 85:15 poly (L-lactide-co- glycolide). This copolymer is formed by combining L-lactide and glycolide, which maximizes the advantageous characteristics of each component and provides a material well suited for craniofacial reconstruction (Figure 1).

85:15 poly (L-lactide-co-glycolide) is a linear, substantially amorphous, random copolymer, and retains approximately 85% of its initial bending strength after 8 weeks (Figure 2).

A significant benefit of this composition is the amorphous microstructure, which is readily resorbed by the body (Figure 3). First, water penetrates the bulk of the device and breaks the chemical bonds along the backbone of the polymer chains in a process called hydrolysis. As the bonds are broken, producing shorter polymer chains, the molecular weight of the polymer decreases, and the strength of the material decreases.

Eventually, the material loses its integrity and breaks down into smaller and smaller particles. These smaller pieces are then phagocytized (ingested and digested by the cells of the body). The polymer is broken down into lactic and glycolic acids, which are subsequently eliminated through natural body metabolism in the form of water and CO2, without toxic tissue accumulation.11

11. miller RA, Brady Jm, Cutright DE. Degradation rates of oral resorbable implants (polylactates and polyglycolates): rate modification with changes in PLA/PGA copolymer ratios. J Biomed Mater Res. 1977;11(5):711-9.

RAPIDSORB Rapid Resorbable Fixation System

L-Lactide (85%)L-lactide polymers are semi- crystalline, characterized by high strength and a long degradation time.

Glycolide (15%)Glycolide polymers are amorphous, characterized by lower strength and more rapid degradation.

Figure 1120

100

80

60

40

20

00 5 10 15 20 25 30

Time (weeks)

Stre

ng

th R

eten

tio

n (

%)

Figure 2

Figure 3

H2O

H2O

H2O

CO2

Lactic and Glycolic Acids

metabolism

Bulk Hydrolysis

Cell

(short polymer chains)

(polymer)

RAPIDSORB Rapid Resorbable Fixation System DePuy Synthes Companies 3

INDICATIONS AND CONTRAINDICATIONS

12. Please see Instructions For Use for complete contraindications, warnings and precautions.

AP view—Frontal bar advanced and fixated with two 2 x 18 hole strut plates (circled)

Intraoperative photos of metopic synostosis reconstruction using rapid resorbable fixation system

Lateral view—Frontal bone fragments reconstructed using contourable mesh (circled)

IndicationsThe DePuy Synthes Companies RAPIDSORB Rapid Resorbable Fixation System is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.

In addition, resorbable meshes, sheets, screws, and tacks may be used in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts, (autograft or allograft), or bone graft substitutes in reconstruction of the craniofacial or mandibular areas.

Contraindications 12

These devices are not intended for use in load-bearing applications, such as the mandible, unless used in conjunction with traditional rigid fixation. The DePuy Synthes Companies RAPIDSORB Rapid Resorbable System is not intended for areas with active or latent infection, or for patient conditions including limited blood supply or insufficient quantity or quality of bone. These devices are not intended for use in the spine.

4 DePuy Synthes Companies RAPIDSORB Rapid Resorbable Fixation System

RAPIDSORB ImPLANTS

The wide assortment of implants in the DePuy Synthes Companies RAPIDSORB Rapid Resorbable Fixation System incorporates a plate design with many features and benefits:

x Beveled edge for reduced palpabilityx Optimized screw recess for low profilex Straight-edged design for greater strengthx Groove identifies top surfacex Cross-slots between holes facilitate bending

0.5 mm 1.2 mm

0.5 mm thick plate with 1.5 mm screw

0.25 mm 0.95 mm

0.25 mm thick plate with 1.5 mm screw

0.8 mm 1.1 mm

0.8 mm thick plate with 1.5 mm screw

0.8 mm 1.6 mm

0.8 mm thick plate with 2.0 mm screw

1.2 mm 1.2 mm

1.2 mm thick plate with 2.0 mm or 2.5 mm screw

Plate/screw profilesLow plate and screw profile minimizes soft tissue irritation, palpability, and the amount of material to be resorbed.

x Implants are available in a range of sizes

1.5 mm Plates

2.0 mm Plate

RAPIDSORB Rapid Resorbable Fixation System DePuy Synthes Companies 5

RAPIDSORB Implants

Screwsx Available in 1.5 mm, 2.0 mm, and 2.5 mm diametersx Cruciform recess allows easy pickup, insertion, and removalx Emergency screws can be placed easily by tapping

through the original screwx 2.0 mm screws can be used with 1.5 mm plates as primary

or emergency screws

6 DePuy Synthes Companies RAPIDSORB Rapid Resorbable Fixation System

RAPIDSORB Implants

Preshaped orbital floor plate can be quickly and easily contoured.

Contourable mesh permits optimal anatomic conformity without cutting or kinking.

RAPIDSORB Rapid Resorbable Fixation System DePuy Synthes Companies 7

RAPIDSORB Implants

The solid sheet allows customization of hole size and location.

Straight row mesh can be cut into desired plate geometries.

8 DePuy Synthes Companies RAPIDSORB Rapid Resorbable Fixation System

RESORBABLE FIxATION INSTRUmENTS

A full line of instrumentation and trays meets the needs of both surgeons and operating room personnel.

Please refer to the RAPIDSORB Rapid Resorbable Fixation Technique Guide for a complete listing of instruments and contouring systems.

Customizable instrument traysx Two customizable resorbable fixation instrument trays

allow storage of preferred instrument combinationsx Translucent lid for visualization of contentsx Optional bending template module snaps onto either

lid for storage

Taps x Available with self-drilling tipsx Choice of hex or mini quick coupling x Available in adjustable or fixed stop lengths

Adjustable stop length, self-drilling tap

Fixed stop length, self-drilling tap

Self-drilling tap

Hex coupling

mini quick coupling

RAPIDSORB Rapid Resorbable Fixation System DePuy Synthes Companies 9

PLATE CONTOURING SySTEmS

Both the Compact Water Bath System and the Water Bath System warm a bath of sterile water or sterile saline solution to quickly heat resorbable plates, meshes, and sheets to a malleable state.

Compact Water Bath System x Smaller footprint takes up less surface area in Operating

Room and in storagex Required custom sterile drape allows for quick set up and

use of the Compact Water Bath

Water Bath Systemx Removable water tray and sterility cover can be

cleaned and sterilized x Reusable sterility cover or disposable

sterile drape allows use in the sterile field

© DePuy Synthes 2015. All rights reserved. DSUS/BIO/0215/0061 7/15 DV

Limited Warranty and Disclaimer: DePuy Synthes Companies 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.

Rx only

Some devices listed in this brochure may not have been licensed in accordance with Canadian law and may not be for sale in Canada. Please contact your sales consultant for items approved for sale in Canada.

Manufactured or Distributed by:

Synthes USA Products, LLC1302 Wrights Lane EastWest Chester, PA 19380 Telephone: (610) 719-5000 To order: (800) 523-0322Fax: (610) 251-9056

www.depuysynthes.com