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Sidus® Stem-Free Shoulder Surgical Technique - United States Version

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* Please note that Adverse Events Reporting for the US Investigational Device Exemption clinical study, the Europe Post-Market Clinical Follow-up study and the Bigliani/Flatow historical control study are located in the Appendix.

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4 | Sidus Stem-Free Shoulder Surgical Technique System Benefits Zimmer Biomet continues to lead the way in bonepreserving arthroplasty solutions with the Sidus StemFree Shoulder System. Sidus Shoulder was launched in Europe in 2012 and a subsequent Post-Market Clinical Follow-up (PMCF) study2 was conducted involving 152 patients. In addition, a clinical IDE (Investigational Device Exemption) study1 was initiated in the United States and Canada in 2015, that included another 95 patients. To date, both studies demonstrate strong clinical performance. Sidus Shoulder is a total shoulder...

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5 | Sidus Stem-Free Shoulder Surgical Technique Minimal bone removal Lean Instrumentation An efficient, bone-sparing solution, wwshould revision become necessary (Figure B) Designed for procedural efficiency due to easy-to-use instrumentation (Figure C) • Humeral shaft is untouched, minimal bone is removed from the metaphysis providing a clean slate for revision. • Single-layer tray weighing less than 10 lbs. • Top of Anchor contains four large windows for both an enhanced view of the humerus during insertion, and also serving as wide osteotome slots which allow for easy disassociation from...

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6 | Sidus Stem-Free Shoulder Surgical Technique Good Bone Quality Soft/Weak bone quality Preoperative A/P x-rays with and without Sidus X-Ray Template Thumb Test Preoperative Considerations Intraoperative Considerations Bone Test Preoperative evaluation of the Humerus using the Sidus Stem-Free Shoulder ­ emplates helps determine t the size of the prosthesis and level of the head resection. The goal is to make a resection that matches the anatomy of the patient. • To achieve a good outcome, the patient must have adequate bone stock to support the fixation of the implant (Figure E). •...

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7 | Sidus Stem-Free Shoulder Surgical Technique Surgical Technique Summary Attach Supraspinatus Alignment Guide Resect Humeral Head at anatomic neck Place Central Pin through Trial Head Size Anchor over Pin Use thumbs to press Anchor in position, followed by impaction Perform trial range of motion Final View Key Revision and Intra-operative Correction Surgical Steps Slide Head Distractor under Head Chisel with Fixation Release to loosen Anchor Add Revision Connector & Impaction/ Extractor Handle and remove Ancho

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8 | Sidus Stem-Free Shoulder Surgical Technique Patient in beach chair position Initial Skin incision Patient Positioning Initial Incision • Place patient in a beach chair position on the edge of the operating table (Figure 1). • Start incision in front of the AC joint 1 to 2 cm lateral from the tip of ­ oracoid running straight c downwards to the humeral delta insertion (Figure 2). • Extend involved shoulder over the edge of the table so the arm can be brought into full extension and adduction. – Armrest is optional. – The upper part of the operating table has to be open on the homolateral...

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9 | Sidus Stem-Free Shoulder Surgical Technique Thumb Screw Slide Finger K-Wire Figure 3 Attach Supraspinatus Alignment Guide Humeral Head Identification, Preparation and Resection Expose humeral head and identify anatomical neck landmarks Two humeral head resection techniques are possible with Sidus Stem-Free ­ houlder Instrumentation: a S freehand cut and an alignment guide “Supraspinatus” resection technique (Figure 3). • Fully expose the humeral head. • Remove any unwanted osteophytes to restore the humerus to near native anatomy. • The resection must start exactly on the denuded...

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10 | Sidus Stem-Free Shoulder Surgical Technique Scrub Nurse Figure 4 Assembly Steps Figure 5 Assembled Guide Alignment Guide Supraspinatus Assembly Instructions Alignment Guide Supraspinatus Disassembly Instructions • Push the Finger  2 into the Slide  3 • Unscrew the Locking Screw  1 (counterclockwise direction) • Screw the Locking Screw 1 into the Slide  3 (clockwise direction) • End of assembly • Pull the Finger  2 out of the Slide  3 • End of disassembly Note: The Alignment Guide Supraspinatus must be completely disassembled for cleaning and steam sterilization.

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11 | Sidus Stem-Free Shoulder Surgical Technique Bare Area Posterior View Anterior view Attach Supraspinatus Alignment Guide around anatomical neck • Step 1: Place the sharp point of the Supraspinatus Alignment Guide Finger on the posterior side of the humeral head. Ensure it is exactly on the anatomic neck (Figure 6). • Step 2: Move the Slide towards the anterior edge of humeral head. Ensure Slide is exactly on the anatomic neck (Figure 7). • Step 3: Secure the Supraspinatus Alignment Guide by rotating the Thumb Screw clockwise (Figure 7). Supraspinatus Alignment Guide Note: Do not resect...

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12 | Sidus Stem-Free Shoulder Surgical Technique Scrub Nurse Assembly Steps Pin Retractor Assembly Instructions Pin Retractor Disassembly Instructions • Slide the Nut  1 over the Clamping Jaw  2 • Unscrew the Nut  1 (counterclockwise direction) • Screw the Nut  1 to the Clamping Jaw  2 (clockwise direction) • Pull the Nut  1 from the Clamping Jaw  2 Note: The Pin Retractor must be completely disassembled for cleaning and steam sterilization.

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13 | Sidus Stem-Free Shoulder Surgical Technique Figure 11 Posterior View 1st K-Wire sets version Anterior View Insert 1st K-Wire to set version The first K-Wire 2x100 mm, the ­ upraspinatus-Pin, S determines the retroversion (Figure 10, 11 and 12). • Place the K-Wire 2x100 mm into the Alignment Guide “Supraspinatus”. • Remove the Alignment Guide “Supraspinatus”. ­ – otate Thumb Screw counter-clockwise and R retract Slide away from bone. Technique Tip: – Use the Pin Retractor 2 mm and power tool. The insertion site of the Supraspinatus tendon to the proximal humerus will guide the position...

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