Integra Total Foot System 2 User manual

Integra®Total Foot System 2
EN – ENGLISH ...........................................2
HR – HRVATSKI...........................................12
CZ – ČEŠTINA ............................................24
DA – DANSK ...............................................36
NL – NEDERLANDS...................................48
FI – SUOMI .................................................60
FR – FRANÇAIS...........................................72
DE – DEUTSCH ..........................................84
IT – ITALIANO.............................................96
JA – 日本語.................................................108
PL – POLSKI................................................120
PT – PORTUGUÊS......................................132
RU – PУССКИЙ.......................................144
SCH – 中文 (简体)...................................156
ES – ESPAÑOL............................................168
SV – SVENSKA............................................180
TR – TÜRKÇE..............................................192

This page is intentionally le blank.

2
Integra®Total Foot System 2
EN – ENGLISH
The Integra® Total Foot System (TFS2) is a system containing bone plates and screws designed for use in the
skeletally mature foot. The plates and screws are intended to be used for stabilization and fixation of fresh
fractures, intra-articular and extra-articular fractures, joint depression and multi-fragmentary fractures.
The subject devices can also be used in revision procedures, joint fusion, and in reconstructing the small bones
of the feet. Available plates, screws and instrumentation are packaged as a single system and organized around
the types of plates described below:
CAUTION: U.S. federal law restricts this device
to sale by or on the order of a physician.
Instructions for Use
This page is intentionally le blank.

3
EN – ENGLISH
FORE FOOT PLATES
1. Open Wedge Plates – The plates are offered with stems ranging from 2-5mm in 0.5mm increments, a 6mm stem,
or without a stem.
2. Universal Forefoot Plates – The plates are available in 7 sizes: 14mm, 16mm, 18mm, 20mm, 22mm, 24mm,
and 30mm.
3. MPJ Fusion Plates – The MPJ Fusion Plate is offered in medium and long lengths and le and right configurations.
4. Tarsalis Plates – The 2-Hole Straight Tarsalis Plate is offered in short and long lengths. The 3-Hole and 10-Hole
Straight Plates are included in the system as standard lengths. The 4-Hole Straight Tarsalis Plate is offered in both
standard and short lengths. The Crescentic Tarsalis Plate is offered in le and right configurations. The 4-Hole
Diamond Plate is available in le and right configurations. The T-Shaped Tarsalis Plates are offered in 4-hole,
5-hole, and, 6-hole configurations. The 5-hole designs are provided in straight, le, and right configurations. The
6-hole is only provided in straight configuration.
OPTIONAL: The 6-hole, 7-hole and 8-hole T-Shaped Tarsalis Plates are available in le and right configurations
upon request.
REAR FOOT PLATES
1. Lapidus Plates – The plate is designed with a 0-6mm step in 1 mm increments (7 sizes) to displace the bones.
2. Interpositioning Plates – The plate is offered with or without a stem to space apart two bones or a joint,
with stems being offered in widths 2-12mm in 2mm increments.

4
EN – ENGLISH
3. Universal Rearfoot Plates – The plates are available in 7 sizes: 14mm, 16mm, 18mm, 20mm, 22mm, 24mm,
and 30mm.
4. Rearfoot Reconstruction Plates – The plates are available in 7-hole, 9-hole and 14-hole versions.
5. Flat line Arthrodesis Plates – The plates are available in 12mm, 14mm and 16mm sizes.
6. Dwyer Displacement Plates – This plate is offered with three different step sizes; 6mm, 8mm, and 10mm
7. Calcaneus Plates – The calcaneus plates are available in small, medium, extra small, mini and mini-long sizes.
8. Fibular Plates – The Fibular plates are available in 3-hole, 4-hole, 5-hole, 6-hole, 7-hole, 8-hole, 10-hole,
and 12-hole versions. The Fibular Tubular plates are available 4-hole, 6-hole, 8-hole, 10-hole, and 12-hole versions.
MATERIAL
The implants included in the Integra TFS2 are manufactured from Ti-6Al-4V Titanium Alloy (ASTM F136). The instru-
mentation is manufactured from biocompatible materials.
INDICATIONS FOR USE
The Integra TFS2 is intended for skeletally mature patients for the following:
• Stabilization and fixation of fresh fractures.
• Intra and extra articular fractures, joint depression, and multi-fragmentary fractures.
• Revision procedures, joint fusion and reconstruction of small bones of the feet.

5
EN – ENGLISH
CONTRAINDICATIONS
• Plates and screws are contraindicated in: active infection, conditions which tend to retard healing such as blood
supply limitations, previous infections, insufficient quantity or quality of bone to permit stabilization of the fracture
complex, conditions that restrict the patient’s ability or willingness to follow postoperative instructions during the
healing process and foreign body sensitivity.
• Cases with malignant primary or metastatic tumors which preclude adequate bone support or screw fixations,
unless supplemental fixation or stabilization methods are utilized.
• Foreign body sensitivity – where material sensitivity is suspected, appropriate tests should be made and sensitivity
ruled out prior to implementations.
• These implants are intended as a guide to normal healing, and are NOT intended to replace normal body structure
or bear the weight of the body in the presence of incomplete bone healing. Delayed unions or non-unions in the
presence of load bearing or weight bearing might eventually cause the implant to break due to metal fatigue. All
metal surgical implants are subjected to repeated stress in use, which can result in metal fatigue.
WARNINGS AND PRECAUTIONS
• No metallic surgical implant should be reused. Any metal implant, once used, should be discarded. Even though it
appears undamaged, it may already have small defects and internal stress paerns which may lead to fatigue failure.
• Correct handling of the implant is extremely important. Avoid contouring metallic implants whenever possible. If
necessary, or allowed by design, the device should not be bent sharply, reverse bent, notched or scratched. All of
these operations can produce defects in the surface finish and internal stress concentrations, which may become
the focal point for eventual failure of the appliance.

6
EN – ENGLISH
• If metal plates or other metallic devices are to be used together with the TFS2, all such devices should be manufac
tured from a metal that has a similar composition to avert possibility of galvanic corrosion or other metallic
reactions.
• Correct selection of the implant is extremely important. The potential for success in fracture fixation is increased
by the selection of the proper size, shape and design of the implants. The patient’s anatomy and indication will
determine the size of the TFS2 plate to be used. The size and shape of the human bones presents limiting
restrictions on the size and strength of implants.
• Postoperative care is extremely important. The patient must be warned that noncompliance with postoperative
instructions could lead to breakage of the implant requiring revision surgery to remove the device.
• The use of TFS2 provides the surgeon a means of bone fixation and helps generally in the management of fractures
and reconstructive surgeries. The implants are intended as a guide to normal healing and are NOT intended to
replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.
Delayed unions or nonunions in the presence of load bearing or weight bearing might eventually cause
the implant to break due to metal fatigue. All metal surgical implants are subject to repeated stress in use which can
result in metal fatigue.
• Failure to immobilize a delayed union or nonunion of bone will result in excessive and repeated stresses which are
transmied by the body to any temporary internal fixation device prior to the healing of the fracture. Due to normal
metal fatigue, these stresses can cause eventual bending or breakage of the device. Therefore, it is important that
immobilization of the fracture site is maintained until firm bony union (confirmed by clinical and roentgenographic
examination) is established.

7
EN – ENGLISH
• No partial weight bearing or non-weight bearing device can be expected to withstand the unsupported stresses
of full weight bearing. Until firm bone union is achieved, the patient should employ adequate external support and
restrict physical activities which would place stress upon the implant or allow movement at the fracture site and
delay healing.
• Detailed wrien instructions on the use and limitations of the device should be given to the patient. If partial
weight bearing is recommended or required prior to firm bony union, the patient must be warned that bending
or breakage of the device are complications which may occur as a result of the weight bearing or muscle activity.
An active patient or a debilitated or demented patient who cannot properly utilize weight support devices may be
particularly at risk during postoperative rehabilitation.
• While the surgeon must make the final decision on implant removal, whenever possible and practical for the
individual patient, fixation devices should be removed once their service as an aid to healing is accomplished,
particularly in younger more active patients.
• The MR environment presents risks to patients with metal implants. Review of the available literature documents
that metal implants may heat resulting in tissue damage and may migrate out of position. They may also cause
artifact affecting image quality. Physicians should take these risks into consideration when recommending MRI
imaging for patients with metal implants. Note: Integra TFS2 has not been evaluated for safety and compatibility in
the MR environment. The Integra TFS2 has not been tested for heating or migration in the MR environment.

8
EN – ENGLISH
STERILITY
The Integra TFS2 system components are provided non-sterile, and must be cleaned and sterilized prior to use. Do
not re-use implants, as they are single use only. Detailed reprocessing instructionsare provided in LC-04-0000-0013.
ADVERSE EVENTS
• Loosening, bending, cracking or fracture of the screw or loss of fixation in bone aributable to nonunion.
• Loss of anatomic position with nonunion or malunion with rotation or angulation.
• Infection, both deep and superficial.
• Allergies and other reaction to the device material.
SURGICAL PROCEDURE
A Surgical Technique brochure is available which outlines the basic procedure for device implantation and the use of
specialized surgical instrumentation. It is the responsibility of the surgeon to be familiar with the procedure before
use of these products. Each surgeon must evaluate the appropriateness of the surgical technique used based on per-
sonal medical training and experience. Copies of the surgical technique may be obtained online at www.integralife.
com, by contacting customer service at 1-800-654-2873, or by contacting your local sales representative.

9
EN – ENGLISH
TRAINING
It is the responsibility of the surgeon to obtain the necessary training prior to implanting this implant. The surgeon
should have specific training, experience, and thorough familiarity with the use of cannulated, non-cannulated,
headless, and snap-off screws. The surgeon must exercise reasonable judgment when deciding which screw type to
use for specific indications.
SYMBOLS USED ON LABELING
2
Do not re-use
Compliance with EU legislation
Consult Instructions for Use
Manufacturer
For prescription use only