SYNPOR SYNTHES POROUS

POLYETHYLENE IMPLANT

Crop

Instruments and implants approved by the AO Foundation.

This publication is not intended for distribution in the USA.

SURGICAL TECHNIQUE
TABLE OF CONTENTS

INTRODUCTION SynPOR2

Clinical Applications 3
Indications and Contraindications

Product Options 4

SURGICAL TECHNIQUE Handling5

Sizing6

Contouring7

Implant Fixation 8

PRODUCT INFORMATION Implants9

Warning
This description alone does not provide sufficient background for direct use of
the instrument set. Instruction by a surgeon experienced in handling these
instruments is highly recommended.

Reprocessing, Care and Maintenance of

Synthes Instruments
For general guidelines, function control and dismantling of multi-part
instruments, please contact your local sales representative or refer to:
www.synthes.com/reprocessing

SynPOR  Surgical Technique  DePuy Synthes    1

SYNPOR
SYNTHES POROUS POLYETHYLENE IMPLANTS

Overview
SynPOR implants are manufactured from an inert, non-
absorbable polymer formulated to contain a network
of open and interconnecting pores approximately
100–250 µm in size. These interconnected pores allow
fibro­vascular tissue i­ngrowth and relative host incorpora-
tion, rather than host encapsulation observed with
smooth-surface implants ¹.

SynPOR implants are well suited for craniofacial recon-

struction and augmentation. The implant’s porous struc-
ture p
­ romotes tissue ingrowth and results in rapid inte-
gration and stabilization.

Features
• Porous structure supports tissue ingrowth
• Smooth implants have one barrier surface allowing
tissue ingrowth on only one side
• Nonabsorbable material
• Semi-rigid material is strong yet flexible
• Contourable and easily shapeable
• Implants may be fixated with screws, tacks, wire
or suture

Material
SynPOR implants are manufactured from ultra-high
­molecular weight polyethylene (UHMWPE), which has a
long history of use as a surgical implant and meets the
requirements of ASTM standard ². In addition, SynPOR
implants have passed ISO standard tests for biocompati-
bility ³. Several SynPOR designs also incorporate titanium
mesh constructed from commercially pure titanium.

1 Yaremchuk, M.J., Facial skeletal reconstruction using

porous polyethylene implants. Plast Reconstr Surg, 2003.
111(6): p. 1818–27
2 A STM F648, Standard Specification for Ultra-High-

Molecular Weight Polyethylene Powder and Fabricated

Form for Surgical Implants.
3 ISO 10993, Biological Evaluation of Medical Devices.

2    DePuy Synthes  SynPOR  Surgical Technique

CLINICAL APPLICATIONS
INDICATIONS AND CONTRAINDICATIONS

Clinical Applications

Orbital augmentation and reconstruction:

• Orbital floor/wall
• Orbital rim
• Enophthalmos
• Lower eyelid retraction

Facial augmentation:
• Malar
• Genioplasty
• Mandibular: angle/body/ramus

Indications*
SynPOR Implants are intended for the augmentation
or reconstruction of bony contours in the craniomaxillo-
facial skeleton in non-load bearing indications only.

Contraindications*
SynPOR Implants should not be used in the following
circumstances:
• The presence of active or latent infections
• Inadequate coverage of healthy, vascularized tissue
• Systemic disorders that may cause slow healing and
increase the possibility of infection and/or rejection of
the implants
• Systemic disorders and limitation in blood supply
should
• Tissue that has been compromised by cancer therapies
• Any degenerative disease process that would adversely
affect proper placement of the implants
• Sinus procedures
• Cranioplasty procedures
• Dura repair or cases where the dura is damaged

SynPOR Implants are not indicated for use in load bear-

ing and unstable indications unless used in conjunction
with appropriate osteosynthesis fixation systems.

* For complete, inidications, contraindications, precautions

and warnings please refer to the instruction for use

SynPOR Surgical Technique DePuy Synthes 3

PRODUCT OPTIONS

SynPOR Sheets
Engineered to maintain an open interconnected porosity
throughout the implant to support tissue ingrowth.

SynPOR Smooth Sheets

Implants have a thin layer of solid polyethylene on the
superior surface to minimize tissue adhesion and porous
polyethylene on the inferior surface to support tissue
ingrowth.
SynPOR Sheet SynPOR Smooth Sheet
• Radiolucency reduces interference with diagnostic
imaging
• Anatomical shapes allow for quick implantation in a
variety of sites with minimal manipulation required
• 50 mm  50 mm sheets for custom shaping
• Multiple thicknesses to meet clinical needs

Note: For smooth implants, place the smooth side of

the implant toward the soft tissue to minimize adhe-
sion and ensure motility of the globe.
SynPOR Orbital Floor Plate SynPOR Fan Plate

SynPOR Titanium Orbital Floor Mesh Plate

The fan-shaped orbital floor plate is embedded in po-
rous sheets.

SynPOR Smooth Titanium Orbital Floor Mesh Plate

The fan-shaped orbital floor plate is embedded in a po-
rous and a smooth sheet. SynPOR Smooth Titanium
Reinforced Fan Plates provide a barrier to minimize soft
tissue adhesion on the superior surface and a porous
surface on the reverse side to support tissue ingrowth.
SynPOR Titanium Orbital Floor Mesh SynPOR Titanium Orbital Floor Mesh
Plate Plate, with exposed fixation holes
• Titanium mesh provides radiographic visibility
• Increased sheet strength and contour retention
• Available with titanium mesh partially exposed or
completely covered for multiple fixation options
• Anatomical shape and radial titanium mesh design
minimize cutting
• Polyethylene sheets reduce sharp titanium edges
after cutting and facilitate insertion
• Fixation hole positions allow for optimal screw
placement
• Available in two thicknesses: 0.8 mm and 1.5 mm SynPOR Smooth Titanium Orbital SynPOR Smooth Titanium Orbital
Floor Mesh Plate Floor Mesh Plate , with exposed
fixation holes

4 DePuy Synthes SynPOR Surgical Technique

HANDLING

SynPOR implants should not be removed from their

sterile packaging until time of implantation.

The implants should be handled with clean, powder-free

gloves to prevent contamination.

Precaution: Do not place implants on surgical

drapes, surgical clothing or any other material that
may contaminate the implants with lint or other
particulate matter. Implants may be placed in ster-
ile saline to prevent contamination.

SynPOR Surgical Technique DePuy Synthes 5

SIZING

SynPOR implants can be easily cut and sculpted with

scissors, mesh cutters and/or scalpel to the desired
shape.

Precaution: Do not use electrosurgical devices to cut

or modify the implants.

Thicker implants
Thicker implants may be adapted to the surgical site
using bone cutters or cutting burrs to achieve the
desired shape. After burring the implant, reestablish
the open pore structure by shaving the outer surface
of the implant with a scalpel.

Multiple pieces
Multiple pieces can be sutured together when thicker
or larger implants are required.

After sizing the implant, rinse in sterile saline solution

to remove loose particles.

6 DePuy Synthes SynPOR Surgical Technique

CONTOURING

SynPOR implants can be contoured by submerging in

hot, sterile saline (over 70° C) for several minutes until
the implant softens. Higher temperatures will improve
the ability to contour the implant.

Remove implant from the hot saline and contour to

the desired shape. If there is too much resistance, return
implant to hot saline.

Allow the implant to cool completely to maintain

achieved shape. Cold, sterile saline can accelerate the
cooling process.

Reheat the implant as necessary to achieve the final

form desired.

SynPOR Surgical Technique DePuy Synthes 7

IMPLANT FIXATION

Stabilize the implant with screws, tacks, wire or suture

as desired.

When using screws, tighten sufficiently to compress the

implant to the bone and minimize screw profile.

Make any final modifications in situ. Feather the edges

of the implant to create a smooth transition and mini-
mize palpability.

Precaution: Take care to remove all carved debris

from the surgical site.

8 DePuy Synthes SynPOR Surgical Technique

IMPLANTS

SynPOR Sheet, sterile

Art. No. Dimension (mm) Thickness (mm)
08.510.110S 5050 0.45
08.510.120S 5050 0.8
08.510.130S 5050 1.5
08.510.140S 5050 3.0

SynPOR Smooth Sheet, sterile

Art. No. Dimension (mm) Thickness (mm)
08.510.220S 5050 0.8

SynPOR Orbital Floor Plate, sterile

Art. No. Dimension (mm) Thickness (mm)
08.510.540S 2424 0.8
08.510.541S 3030 0.8
08.510.542S 3535 0.8
08.510.543S 2424 1.5
08.510.544S 3030 1.5
08.510.545S 3535 1.5

SynPOR Smooth Orbital Floor Plate, sterile

Art. No. Dimension (mm) Thickness (mm)
08.510.640S 2424 0.8
08.510.641S 3030 0.8
08.510.642S 3535 0.8

SynPOR Fan Plate, sterile r

Art. No. Radius (mm) Thickness (mm)
08.510.546S 35 0.8
08.510.547S 35 1.5

SynPOR Smooth Fan Plate, sterile

Art. No. Radius (mm) Thickness (mm)
08.510.646S 35 0.8

SynPOR Surgical Technique DePuy Synthes 9

Implants

SynPOR Titanium Reinforced Fan Plate, sterile

Art. No. Radius (mm) Thickness (mm)
08.520.120S 44.6 0.8 r

08.520.121S 43.6 0.8 with exposed

fixation holes
08.520.130S 44.6 1.5
08.520.131S 43.6 1.5 with exposed
fixation holes SynPOR/SynPOR Smooth Titanium
Orbital Floor Mesh Plate

SynPOR Smooth Titanium Reinforced

Fan Plate, sterile
Art. No. Radius (mm) Thickness (mm)
08.520.220S 44.6 0.8
08.520.221S 43.6 0.8 with exposed r

fixation holes
08.520.230S 44.6 1.5
08.520.231S 43.6 1.5 with exposed
fixation holes

SynPOR/SynPOR Smooth Titanium

Note: SynPOR porous polyethylene implants are
Orbital Floor Mesh Plate, with exposed
provided sterile and pyrogen free, for single-patient fixation holes
use. Do not resterilize.

11    DePuy Synthes  SynPOR  Surgical Technique

 © DePuy Synthes Biomaterials, a division of Synthes GmbH. 2015.  All rights reserved.  036.000.327 DSEM/BIO/0315/0028 04/15

Crop

Synthes GmbH
Eimattstrasse 3
4436 Oberdorf
Switzerland This publication is not intended for distribution in the USA.
Tel: +41 61 965 61 11
Fax: +41 61 965 66 00 All surgical techniques are available as PDF files at
www.depuysynthes.com www.synthes.com/lit 0123