Inion Freedom™ – A Biodegradable Solution Inion Freedom

TM
 Contents

Company Introduction 2
Inion® Core Technology 3
Inion FreedomTM 4
Inion FreedomPlateTM 5
Inion FreedomScrewTM 6
Ordering Information 7
Ordering Information 8
Inion OTPSTM Mesh System 9

1
 Company Introduction

Inion Oy is a medical device company focused on In 2001, only 14 months after its corporation, the
the development and manufacture of innovative company was able to develop its proprietary Inion®
biodegradable and bioactive medical implants Family of Biodegradable Materials and launch its first
based on proprietary biomaterials, which give rise FDA-cleared products onto the market. This was
to significant advantages from both a patient’s made possible by the help of Inion’s scientists’ over
and a clinician’s perspective. The company’s key 25 years of expertise in processing of biodegradable
market segments are Specialty Orthopaedics and polymers for medical use, as well as, know-how
Craniomaxillofacial. in clinical and regulatory requirements, and links
with world-leading biomaterials manufacturers,
Inion was founded in 1999 by an international group universities and clinics. Since that initial launch,
of experienced professionals, including surgeons Inion has operated in five main clinical areas:
and materials specialists, to create medical craniomaxillofacial, dental, orthopaedic trauma,
solutions that were not available to the surgical sports medicine and spinal surgery.
community. Initially their focus was perfecting
biodegradable materials that could be used to The company is based in Tampere, Finland, a
manufacture a wide range of medical implants. city known as a center of excellence in health and
biotechnology research. The modern 4500m2
headquarters houses state-of-the-art manufacturing,
laboratory and office facilities as well as ISO
class 7 cleanrooms. The company’s design and
2
manufacturing processes conform to ISO 13485
and FDA 21 CFR 820.

Over 25 years of expertise in processing of biodegradable

polymers for medical use.
 Inion® Core Technology

Inion’s core biomaterials technology, Inion® By blending four safe and well-characterized rigid
Polymers, represents a range of proprietary and elastic medical polymers in varying proportions,
biodegradable biomaterials with great potential for Inion has generated more than 40 Inion® blends.
use in medical implants that enhance the healing Typically, Inion® implants retain most of their initial
of bone or soft tissue injuries to the skeleton. A strength for 9-12 weeks after implantation and
key benefit of Inion® implants is that they provide degrade entirely in 2-4 years, but depending on
support during the healing process, prior to safely the clinical requirements, these parameters can be
and completely degrading into carbon dioxide and optimized by varying the composition of the blend.
water at a predictable rate in the body. Inion develops implants in consultation with leading
surgeons, to ensure they meet specific clinical
Fundamental to Inion’s approach is its thorough performance criteria.
understanding of the requirements for bone and
tissue healing. Inion recognizes that different types Medical implants made from Inion® Polymers, such
of injuries require fixation using implants with as plates, pins and screws, can be made for the
characteristics that provide the right combination of fixation of a wide range of fractures or soft tissue
strength, rigidity, malleability and biodegradability to injuries (torn tendons or ligaments) throughout the
produce a successful clinical outcome. skeleton.

By blending four safe and well-characterized rigid and elastic

biodegradable polymers in varying proportions, Inion has
generated more than 40 Inion® Polymer blends.
 Inion FreedomTM

Inion FreedomTM is the only full biodegradable

system with both plates and screws. Inion
FreedomPlateTM and Inion FreedomScrewTM
together form a resorbable locking plate system,
which is unique of its kind.

The initial principle behind the development of

the Inion FreedomTM products has been to keep
everything as simple and compatible with existing
operation techniques as possible, and additionally,
to offer clear benefits with full versatility and low
inventories.

The Inion FreedomTM offers:

Ease of use with versatile products, “one screw –
one plate” ideology
Contours perfectly to any anatomy
Allows free screw placement to any desired
position and angle
Screws interlock to the plate
4
Low-profile construct
Transparent and radiolucent
Low inventory of plates and screws
...and is biodegradable!

Over the decades, one of the known shortcomings

of resorbable products has been the initial handling
properties during screw insertion in the
demanding orthopaedic fixations. With the Inion
FreedomTM, Inion has overcome this issue
by developing new resorbable screws with
significantly higher strength values and better
handling properties compared to the old systems.

These exceptional new properties are based on

Inion’s patented raw material combinations, unique
manufacturing methods and in-house material
blending. Inion is the only manufacturer in the
world tailoring the most optimal resorbable material
compounds according to each indication.
 Inion FreedomPlateTM

Product description

Inion FreedomPlateTM is a versatile fracture fixation

plate. The system includes a fully customizable
plate which perfectly contours to all anatomies, and
fixation screws which can be implanted polyaxially
to provide the best possible fixation.

Benefits

Customized plate for every patient by thermo

forming and cutting to any desired size and shape
Further plate contouring possible intraoperatively
to meet challenging anatomies
Low profile – low risk of tissue irritation
Variable screw angulations
Screws interlock to the plate – low risk of screw
back-out
Free placement of the screws
Transparent and radiolucent
Low inventory of plates and screws 5

Indications

Maintenance of alignment and fixation of Maintenance of relative position of weak bony tissue
bone fractures in trauma and reconstructive procedures, i.e.:
osteotomies bone grafts
arthrodesis bone graft substitutes
bone fragments in comminuted fractures
of long bones, flat bones, short bones, irregular
bones, appendicular skeleton and thorax, in the
presence of appropriate additional immobilization or
fixation
 Inion FreedomScrewTM

Product description

Inion FreedomScrewTM is a strong and fully versatile

resorbable screw for orthopaedic fixations. Because
of its unique manufacturing method and intelligent
technical properties, Inion FreedomScrewTM offers
many clear benefits for the operating surgeon who
appreciates easiness, reliability and versatility from Disposable insertion adapter and compatibility with
the implant. generic (ISO, ASIF, AO) instrumentation

Benefits

High strength properties to meet the challenges

of demanding orthopaedic fixations
Low screw head profile and ability to create "a
new screw head" at a chosen point of the screw
shaft by a temperature cautery
Good bite! - New screw profile with improved pull-out
Delivered with a disposable metallic adapter strength properties
Compatible with most of the universal
instrumentation used in hospitals around the
6 world: ISO, ASIF, AO
Can be cut to any desired length during the
operation
Screws interlock with the plate
Transparent and radiolucent
Low inventory quantities
Memory Effect – ability to create new screw heads
along the shaft by temperature cautery

Indications

The Inion FreedomScrew™ is intended for maintenance of alignment and fixation of bone fractures,
comminuted fractures, osteotomies, arthrodesis or bone grafts (i.e., autografts or allografts) in the presence of
appropriate additional immobilization (e.g., rigid fixation implants, cast or brace).

In addition, the Inion FreedomScrew™ 3.5/4.0/4.5 mm products are specifically intended for use in following
indications:
A. General indications: maintenance of reduction and fixation of cancellous bone fractures, osteotomies or
arthrodesis of the upper extremity, ankle and foot in the presence of appropriate brace and/or immobilization.
B. Specific indications: fractures and osteotomies of the malleoli, and ankle fractures.
 Ordering Information - Plates and Screws

Inion FreedomPlate™
Art. No. Description Qty
FRF-1065 20 x 65 mm concave plate 1
FRF-1066 20 x 100 mm concave plate 1

Inion FreedomScrew™ - Fully threaded

Art. No. Description Qty
OSA-2014 FreedomScrew 2.0 x 14 mm 1
OSA-2020 FreedomScrew 2.0 x 20 mm 1
OSA-2716 FreedomScrew 2.7 x 16 mm 1
OSA-2740 FreedomScrew 2.7 x 40 mm 1
OSA-3530 FreedomScrew 3.5 x 30 mm 1
OSA-3545 FreedomScrew 3.5 x 45 mm 1
OSA-4540 FreedomScrew 4.5 x 40 mm 1
OSA-4555 FreedomScrew 4.5 x 55 mm 1

Inion FreedomScrew™ - Partially threaded (LAG)

Art. No. Description Qty
OSB-3530 FreedomScrew 3.5 x 30 mm (LAG) 1
OSB-3535 FreedomScrew 3.5 x 35 mm (LAG) 1
OSB-3540 FreedomScrew 3.5 x 40 mm (LAG) 1
OSB-3545 FreedomScrew 3.5 x 45 mm (LAG) 1
OSB-4535 FreedomScrew 4.5 x 35 mm (LAG) 1 7
OSB-4540 FreedomScrew 4.5 x 40 mm (LAG) 1
OSB-4545 FreedomScrew 4.5 x 45 mm (LAG) 1
OSB-4550 FreedomScrew 4.5 x 50 mm (LAG) 1
OSB-4555 FreedomScrew 4.5 x 55 mm (LAG) 1

Inion FreedomScrew™ - Fully threaded, Cannulated

Art. No. Description Qty
OSC-3530 FreedomScrew 3.5 x 30 mm, Cannulated 1
OSC-3545 FreedomScrew 3.5 x 45 mm, Cannulated 1
OSC-4540 FreedomScrew 4.5 x 40 mm, Cannulated 1
OSC-4555 FreedomScrew 4.5 x 55 mm, Cannulated 1

Inion FreedomScrew™ - Fully threaded, Cannulated - Syndesmosis Screw

Art. No. Description Qty
OSC-4090 FreedomScrew 4.0 x 90 mm, Cannulated 1

Inion FreedomScrew™ - Partially threaded (LAG), Cannulated

Art. No. Description Qty
OSD-3530 FreedomScrew 3.5 x 30 mm (LAG) , Cannulated 1
OSD-3535 FreedomScrew 3.5 x 35 mm (LAG), Cannulated 1
OSD-3540 FreedomScrew 3.5 x 40 mm (LAG), Cannulated 1
OSD-3545 FreedomScrew 3.5 x 45 mm (LAG), Cannulated 1
OSD-4535 FreedomScrew 4.5 x 35 mm (LAG), Cannulated 1
OSD-4540 FreedomScrew 4.5 x 40 mm (LAG), Cannulated 1
OSD-4545 FreedomScrew 4.5 x 45 mm (LAG), Cannulated 1
OSD-4550 FreedomScrew 4.5 x 50 mm (LAG), Cannulated 1
OSD-4555 FreedomScrew 4.5 x 55 mm (LAG), Cannulated 1
 Ordering Information - Instruments

IFS-9901 Complete instrument set and tray

IFS-2001 Drill bit 1.5 mm

IFS-2002 Tap 2.0 mm
IFS-2701 Drill bit 2.0 mm
IFS-2702 Tap 2.7 mm
IFS-3501 Drill bit 2.5 mm
IFS-3502 Tap 3.5 mm
IFS-3503 Drill bit 2.7 mm, cannulated
IFS-3504 Tap 3.5 mm, cannulated
IFS-4004 Tap 4.0 mm, cannulated
IFS-4501 Drill bit 3.2 mm
IFS-4502 Tap 4.5 mm
IFS-4503 Drill bit 3.2 mm, cannulated
IFS-4504 Tap 4.5 mm, cannulated
IFS-9001 Screwdriver shaft, hex 2.5 mm
IFS-9002 Screwdriver shaft, hex 3.5 mm, cannulated
IFS-9011 Holding sleeve for 2.0/2.7 mm screws
IFS-9012 Holding sleeve for 3.5 - 4.5 mm screws
IFS-9021 Drill sleeve 1.5/2.0 mm, for 2.0 mm screws
8
IFS-9022 Drill sleeve 2.0/2.7 mm, for 2.7 mm screws
IFS-9023 Drill sleeve 2.5 - 3.5 mm, for 3.5 mm screws
IFS-9024 Drill sleeve 3.2 - 4.5 mm, for 4.0/4.5 mm screws
IFS-9031 Countersink for 2.0/2.7 mm screws
IFS-9032 Countersink for 3.5 - 4.5 mm screws, cannulated
IFS-9041 Depth gauge for 2.7/3.5 mm screws
IFS-9042 Depth gauge for 2.7 - 4.5 mm screws, with K-wire
IFS-9043 K-wire 1.6 mm for 4.0/4.5 mm screws
IFS-9051 Screw cutting pliers
IFS-9052 Scale for 2.0/2.7 mm screws
IFS-9053 Scale for 3.5 - 4.5 mm screws
INS-9093 Small handle, cannulated (set contains two pieces of INS-9093)
INS-9120 Large handle, cannulated
IFS-9801 Instrument tray

HTC-0000 Low Temperature Cautery

ACC-9810 Inion Thermo+TM water bath 230v
ACC-9840 Inion Thermo+TM water bath 110v
ACC-9802 Inion ThermoTM drape
IFS-4003 Drill bit 3.2 mm, cannulated (same as IFS-4503)
IFS-9061 K-wire 1.25 mm for 3.5 mm screws
IFS-9062 K-wire 1.6 mm for 4.0/4.5 mm screws
 Inion OTPSTM Mesh System

Product description

The Inion OTPSTM Biodegradable Mesh Fixation

System is designed for graft containment and to
sustain the relative position of bone fragments.
Inion FreedomTM screws can be used for fixation of
the mesh.

Benefits

Contours perfectly to patient anatomy

Low profile – low risk of tissue irritation
Variable screw angulations
Flexible placement of the screws
Transparent and radiolucent

Indications

Intended to sustain the relative position of

weak bony tissue, e.g., bone grafts, bone graft
substitutes, or bone fragments from comminuted
fractures. Inion OTPSTM Mesh System
9
Indicated for cement restriction in total joint Art.No. Description Qty
arthroplasty procedures.
MSH-1035 Mesh plate, 14 x 14 holes 1

Only when used in conjunction with traditional rigid

fixation, these implants are intended to sustain the
relative position of weak bony tissue in trauma and
reconstructive orthopaedic procedures involving
the following:
- Long bones
- Flat bones
- Short bones
- Irregular bones
- Appendicular skeleton
- Thorax

When used alone (without traditional rigid fixation),

these implants are intended to maintain the relative
position of bone grafts or bone graft substitutes in
reconstructive orthopaedic procedures involving:
- Tumor resections where bone strength has not
been compromised
- Iliac crest harvest sites
INION OY INION INC
Lääkärinkatu 2 2800 Glades Circle
FI-33520 Tampere, FINLAND Suite 138, Weston
tel: +358-10-830 6600 FL 33327
fax: +358-10-830 6601 USA
email: info@inion.com Toll-free tel: 866-INION-US
internet: www.inion.com tel: 954-659-9224·fax: 954-659-7997

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Version 2 12/2014