TORNIER AEQUALIS ASCEND FLEX

1 SURGICAL TECHNIQUE TORNIERAEQUALIS ASCEND FLEXC onvertible shoulder SystemTable of Contents: 2 AEQUALIS ASCEND FLEX Overview ..4-13 Intended Use ..14 Indications/Contraindications ..14-17 Pre-Operative Planning ..17 Delto-Pectoral Humeral Exposure ..18-19 Anatomic ..18 Reversed ..19 Supero-Lateral Humeral Exposure ..20 Humeral Head Preparation and Resection ..21-24 Anatomic ..21 Reversed ..24 Distal Preparation ..25-26 Proximal Preparation ..27-28 Delto-Pectoral Approach ..27 Supero-Lateral Approach ..28 Metaphyseal Compaction ..29-32 Assembling the Compactor ..30 Compacting ..31 Locking the Compactor ..32 Surface Planning ..33 Protecting the resection ..34 Anatomic Preparation ..35-43 Trialing Humeral Head Components ..35 Trial Reduction ..37 Mobility Testing ..37 Removing the Trial Construct ..37 Final Implantation ..38 Back Table Assembly ..39In-Vivo Assembly ..40 Testing and Closure ..42 Rehabilitation ..423 Reversed Preparation ..44-56 Trialing Reversed Components.

2 44 Reversed Tray/Insert Overview ..44 Understanding Humeral Movement with Offset Trays ..46 Selecting the Reversed Tray Offset ..47 Trial Reduction ..48 Mobility Testing ..48 Trial Adjustments ..49 Removing the Trial Construct ..50 Final Implantation/Back Table Assembly ..51In-Vivo Assembly ..53 Testing and Closure ..55 Complications ..55 Rehabilitation ..56 Revision Preparation ..57-61 Addressing Recurrent Instability ..57 Addressing Conversion ..58 AEQUALIS ASCEND FLEX Components ..62-79 System Compatibility and Mismatch Charts ..80-83 Continuing the AEQUALIS LegacyTornier first introduced the key principles for anatomic shoulder reconstruction with the launch of the AEQUALIS shoulder System nearly two decades ago. The AEQUALIS shoulder System was born out of a landmark study of the proximal humerus performed by Gilles Walch, and Prof. Pascal Boileau, which detailed four anatomic variables: version, inclination, medial offset and posterior offset.

3 Building upon this legacy and remaining true to its principles, the AEQUALIS ASCEND FLEX Convertible shoulder System has given rise to the next generation of anatomic implant design. Derived from an extensive 3 dimensional CT database of humeral specimens, the AEQUALIS ASCEND FLEX prosthesis design mimics the internal humeral geometry and is the first humeral stem that is truly anatomic from the inside out. The AEQUALIS ASCEND FLEX convertible prosthesis has been carefully built upon the TORNIER legacy and clinical understanding of the AEQUALIS anatomic and reversed systems. The evolved implant design and instrumentation has been developed and evaluated to make no compromises with surgical efficiency, implant accuracy, and overall system flexibility. GILLES WALCH, AEQUALIS ASCEND FLEX Convertible shoulder System provides anatomic and reversed options within a single system offering precise intra-operative implant-to-patient fit and easy conversion to reversed if ASCEND FLEXC onvertible shoulder SystemSimplified shoulder Reconstruction Begins HereThe AEQUALIS ASCEND FLEX stem provides a platform for anatomic, reversed, and conversion procedures.

4 The universal female taper connection provides the simplicity of one stem and one technique for three different procedures. In addition, the short stem design eliminates canal-based constraints to allow for anatomic stem placement, preserves bone stock or future prosthetic intervention, and addresses the potential effects of stress shielding. This new system also offers the time-saving benefit of press-fit PreservationThe short stem design preserves bone stock for future prosthetic intervention both proximally and Preserving GeometryUnlike traditional stems, the curved stem design preserves the supraspinatus tendon insertion and preserves greater tuberosity bone Bone PreservationShort stem preserves distal canal for future surgical FixationThe AEQUALIS ASCEND FLEX Convertible shoulder System is available with a proximal PTC titanium plasma spray coating for press-fit application to save time in the OR. It is also available in a highly polished surface finish for cemented use and long stem options in both press-fit and cemented designs to address clinical need and surgeon (Standard & Long)Cemented (Standard & Long)78 Simply ASCEND FLEXAEQUALIS ASCEND FLEX implants eliminate the unnecessary steps of stem removal, added trauma to the patient, and potential increase in complications during conversion from an anatomic to reversed prosthesis.

5 Its unique, adaptable implants provide a means to relieve soft tissue tension, resulting in more predictable reduction and reduced operative time without the need for additional humeral ConversionUnique high and low offset reversed trays dial to a lateral position, moving the humerus medially and relieving capsular tension from the surrounding soft tissues to deliver a predictable trays provide up to of medial soft tissue reliefHumeral position using centered reversed trayReversed Low High Offset10 Simply AEQUALIS ASCEND FLEX Convertible shoulder System achieves accurate and efficient restoration of natural shoulder biomechanics across a wide range of patients by addressing the variables associated with humeral inclination, stem orientation within the humerus, and head positioning on the resected Stem AlignmentThe anatomically curved short stem design more easily achieves anatomic alignment and reduces the extra steps commonly performed with traditional length canal-dependent straight stems to obtain proper head Resection AccuracyThe AEQUALIS ASCEND FLEX planers may be used to correct imperfections in resected humeral cut surfaces to ensure flush seating of the humeral head and a smooth transition between the head and Stem Position & High O set HeadCentral Stem Position & Low O set , Accurate, Anatomic RestorationRegardless of stem position within the resected humeral surface, low and high eccentric heads infinitely dial to quickly and accurately create an anatomic AEQUALIS ASCEND FLEX reversed implants reduce scapular notching while maximizing abduction, adduction, and rotation, providing the ideal range of motion for activities of daily living.

6 Extensive reversed glenoid options provide optimal fixation and intra-operative flexibility for varying patient AbductionTraditional Centered MetaphysisInability to offset a centrally constrained metaphysis may lead to early acromial impingement with the greater ASCEND FLEX Offset Reversed Adapter Offset reversed trays increase abduction compared to traditional centered metaphysis designs by reducing acromial impingement with the greater and 25mm baseplate diameters, as well as standard and long post options, maximize fixation for a wide variety of patient anatomies and conditions. Options such as the lateralized sphere and BIO-RSA technique, provide surgeons with additional opportunities to increase range of motion and reduce scapular notching (please refer to the BIO-RSA Surgical Technique for more details). AEQUALIS ASCEND FLEXGRAMMONTI mproved Adduction & Reduced NotchingThe 145 humeral inclination of AEQUALIS ASCEND FLEX increases adduction with reduced inferior scapular impingement when compared to the Grammont Glenoid CompatibilityLong Post BaseplateStandard Post Baseplate29mm Baseplate25mm BaseplateLateralized SphereBIO-RSAO ptimized RotationMedial-lateral reversed tray adjustability allows precise soft tissue tensioning for optimized internal and external the reversed tray lateralizes the humerus to remove soft tissue laxity and improve rotation.

7 Conversely, dialing the tray laterally can reduce excess tension for easier UseThe AEQUALIS ASCEND FLEX Convertible shoulder System is intended for use as:A replacement of shoulder joints in primary anatomic or primary replacement of other shoulder joint devices in case of revisions, if sufficient bone stock AEQUALIS ASCEND FLEX Convertible shoulder System also allows for conversions from anatomic to reverse shoulder prosthesis in case of for UseIn Anatomic:The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total AEQUALIS ASCEND FLEX Convertible shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The AEQUALIS ASCEND FLEX Convertible shoulder System is indicated for use as a replacement of shoulder joints disabled by: Rheumatoid arthritis with pain.

8 Non-inflammatory degenerative joint disease ( osteoarthritis and avascular necrosis). Correction of functional deformity. Fractures of the humeral head. Traumatic arthritis. Revision of other devices if sufficient bone stock Technique15IN REVERSE:The AEQUALIS ASCEND FLEX Convertible shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by: Rheumatoid arthritis. Non-inflammatory degenerative joint disease ( osteoarthritis and avascular necrosis). Correction of functional deformity. Fractures of the humeral head. Traumatic arthritis. Revision of the devices if sufficient bone stock reversed adapter is indicated for use as components of the AEQUALIS ASCEND FLEX Convertible shoulder System total shoulder replacement and for transformation of the AEQUALIS ASCEND FLEX Convertible shoulder System into reverse shoulder prosthesis without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle.

9 The components are permitted to be used in the transformation from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthropathy is associated with a massive and non-repairable rotator : All components are single use. The coated humeral stem is intended for cemented or cementless use. The non-coated humeral stem is for cemented use only. The all-poly glenoid components are intended for cemented use only. The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation. Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of Ti and Ti alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt for Use In AnatomicAbsolute contraindications for shoulder arthroplasty: Active local or systemic infection, sepsis and osteomyelitis.

10 Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components. Poor bone quality where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or contraindications for shoulder arthroplasty: Uncooperative patient or patient with neurologic disorders who are not capable of following directions. Osteoporosis. Metabolic disorders which may impair bone formation. Osteomalacia. Distant foci of infections which may spread to the implant site. Rapid joint destruction, marked bone loss or bone resorption apparent on ReverseAbsolute contraindications for shoulder arthroplasty: Poor quality and insufficient quantity of glenoid bone stock. Pre or per-operative glenoid fracture. Acromion fracture. Non-functional deltoid or external rotator muscles. Active local or systemic infection, sepsis and osteomyelitis. Elevation of sedimentation rate unexplained by other disease, elevation of WBC count, or marked shift in WBC differential count.