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Element

Product catalog summary
Introduction
The document details the design and operative technique for the Novation® Comprehensive Hip System, specifically the Novation Element™. This system is designed for primary total hip replacement, including femoral stems, acetabular components, and surgical tools.

Design Philosophy
The Novation Element™ features a fully coated Hydroxyapatite (HA) stem for stability and osseointegration. It includes proximal horizontal and vertical distal grooves to convert hoop stress into compressive loads, facilitating insertion through low-profile incisions and compatibility with various surgical approaches.

Pre-Operative Planning
Traditional templating methods are used in pre-operative planning to determine offset, limb length, and stem size, with X-ray reference points aiding in reconstructing the femoral anatomy.

Operative Technique Overview
The technique involves osteotomy guide placement, proximal femur opening, femoral canal entry, and trial component insertion to ensure implant alignment and stability.

Detailed Operative Technique
  • Approach and Exposure: Describes the posterior lateral approach compatible with standard surgical exposures.
  • Dislocation and Osteotomy: Achieved through flexion, adduction, and internal rotation, with precise osteotomy guide alignment.
  • Femoral Preparation: Involves femoral canal opening and broaching with progressive sizes for fit and stability.
  • Trial Reduction: Trial components are inserted to assess fit and function before final implantation.
  • Final Reduction: Involves femoral stem insertion, impaction, and final range of motion checks.
  • Closure: The wound is closed per the surgeon's preferred method.


System Specifications and Implant Ordering Information
Specifications for femoral heads and stems, including size, neck length, and offset options, are provided along with ordering information.

Instrument Listing
A detailed list of required instruments, including catalog numbers and descriptions, is included.

Contact Information
Exactech Corporate Headquarters is in Gainesville, FL, USA, with contact numbers provided. Contact details for Exactech offices in Asia, Canada, Japan, the UK, and France are also listed.

Product Information
The document references the Exactech Novation® Comprehensive Hip System and directs users to the Instructions for Use for more information. Contact details for Exactech, Inc. in Gainesville, Florida, are provided for further inquiries.

European Representation
MediMark® Europe is the authorized European representative, with contact information for their office in Grenoble, France.
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Catalog excerpts

Element-1

Operative Technique Renewing Innovations. Enduring Solutions.

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Element-2

INTRODUCTION Like the art of fine woodworking, the Novation® Comprehensive Hip System design began with the end in mind. Before launching into development, Exactech’s engineers and design team surgeons established a comprehensive plan. Their goal: to provide a system of femoral stems, acetabular components and surgical instrumentation that would address any situation encountered during primary total hip replacement. They let science be their guide and conducted an extensive research review to identify the best of the best in design and materials. These proven features were blended with masterfully...

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Element-3

PRE-OPERATIVE PLANNING Tools choice is approximately at the center of rotation of the templated acetabulum. Note: Most of the time the chosen prosthetic head (neck length) does not line up with the center of rotation of the acetabulum or even with a mark in the center of the femoral head.The appropriate lateral offset, either Standard or Extended, can be recorded at this time. The head usually is positioned proximal and medial to the center of rotation of the acetabulum. In effect, at the end of the operation the surgeon will be pulling on the limb and lifting the prosthetic femoral head into...

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Element-4

OPERATIVE TECHNIQUE OVERVIEW Osteotomy Guide Placement Opening of the Proximal Femur with Box Osteotome Entry into Femoral Canal Calcar Preparation (Optional) Trial Component Insertion 2

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Element-5

Broach Assembly/ Disassembly Broach Insertion Femoral Stem Insertion Femoral Head Impaction 3

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Element-6

Detailed OPERATIVE TECHNIQUE Approach and Exposure The Novation femoral stems are compatible with any standard surgical exposure. In this operative technique, the posterior lateral approach is described. Dislocation and Osteotomy A. Hip Dislocation The hip should be dislocated by flexion, adduction and internal rotation. Placing a bone hook around the femoral neck may help in difficult cases. Soft tissues along the intertrochanteric line to the proximal border of the lesser trochanter should be cleared. When tight, the gluteus maximus tendon may be released to improve exposure. The limb should...

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Element-7

B. Broach Assembly/Disassembly The Element Broach Handle is assembled to the Element Broach by pulling back the trigger while inserting the rectangular body of the Element Broach Handle into the superior aspect of the Broach and releasing the lever (Figure 4). Care should be taken to ensure that the assembly of the instruments is correct. C. Femoral Broaching Broaching is performed with progressive broach sizes, beginning with the smallest Broach. The Broach is inserted into the femoral canal in a few degrees of anteversion (Figure 5). The surgeon should alternate impaction and withdrawal of...

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Element-8

D. Calcar Preparation (Optional) Calcar planing can be performed, if desired, in order to remove any bone that protrudes above the level of the impacted Element Broach by guiding the Calcar Planar Assembly into the hole on the interior surface of the broach attachment opening (Figure 6). Calcar Planar Blade Replacement - If necessary, a Replacement Calcar Planar Blade can be used to ensure proper removal of excess bone. Use the Calcar Planar Blade Removal Tool to remove the used blade, replace it with a new blade and tighten with the Removal Tool. Trial Reduction A. Trial Component Insertion...

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Element-9

Final Reduction A. Femoral Stem Insertion Figure 8 Femoral Stem Insertion The appropriate femoral stem is chosen and assembled to the Offset Stem Inserter. The femoral stem is impacted taking care to ensure correct rotational alignment, version and depth (Figure 8). It may be necessary to allow the bone to adapt to the implant as it is being impacted. Another trial reduction can be performed with the final femoral stem and Femoral Head Trial. B. Femoral Head Impaction The taper of the femoral stem should be clean and dry. The selected femoral head component is placed onto the taper of the femoral...

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Element-10

System Specifications and implant ordering information Lateral Offset Element Stem Details Size (mm) Standard Lateral Offset with following head lengths (mm) Extended Lateral Offset with following head lengths (mm) Stem Length Note: For each change in head length, vertical leg length changes approximately 2.5mm. Femoral Head Ordering Information Size (mm) 8 * Stem length is measured from medial resection level ** Skirted heads

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Element-11

Femoral Stem Ordering Information Size (mm) Collarless Standard Offset Collared Extended Offset Standard Offset

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Element-12

INSTRUMENT LISTING Catalog Number Part Description 165-31-00 Novation Element Core Instrument Case 109-00-00 Universal Femoral Stem Extractor 113-03-04 T-Handle Starter Reamer 12/14 Femoral Head Impactor

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Element-13

Catalog Number Part Description 161-00-06 Slap Hammer Adapter 161 -00-07 Replacement Calcar Planar Blade 161 -00-24 Calcar Planar Assembly 161 -00-25 Calcar Planar Blade Removal Tool 165-00-05 Novation Element Osteotomy Guide

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Element-14

Catalog Number Part Description Novation Element Femoral Broach/Trial Instrument Case 22mm Femoral Head Trial, 12/14, +0mm 22mm Femoral Head Trial, 12/14, +3.5mm 22mm Femoral Head Trial, 12/14, +7mm 22mm Femoral Head Trial, 12/14, +10mm 28mm Femoral Head Trial, 12/14, O-Ring, -3.5mm 28mm Femoral Head Trial, 12/14, O-Ring, +0mm 28mm Femoral Head Trial, 12/14, O-Ring, +3.5mm 28mm Femoral Head Trial, 12/14, O-Ring, +7mm 28mm Femoral Head Trial, 12/14, O-Ring, +10mm 32mm Femoral Head Trial, 12/14, O-Ring, -3.5mm 32mm Femoral Head Trial, 12/14, O-Ring, +0mm 32mm Femoral Head Trial, 12/14, O-Ring,...

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Element-15

Catalog Number Part Description Element Broach Handle Element Broach, Size 8 Element Broach, Size 9 Element Broach, Size 10 Element Broach, Size 11 Element Broach, Size 12 Element Broach, Size 13 Element Broach, Size 14 Element Broach, Size 15 Element Broach, Size 16 Element Broach, Size 17 Element Broach, Size 18 Element Standard Offset Neck Trial, Size 8-10 Element Standard Offset Neck Trial, Size 11-13 Element Standard Offset Neck Trial, Size 14-18 Element Extended Offset Neck Trial, Size 8-10 Element Extended Offset Neck Trial, Size 11-13 Element Extended Offset Neck Trial, Size 14-18 Novation...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.