Summary InSet™ Reverse Shoulder System is a non-constrained reverse glenohumeral prosthesis intended for total shoulder replacement, comprising a humeral stem, modular tray, UHMWPE bearing, glenoid baseplate, locking/set screw, compression screw, supplementary screws, and a metal glenosphere. Baseplate intended for cementless application with the addition of screw fixation; humeral stem may be implanted by press-fit or cement fixation. Platform overview and related implants. Related Implants InSet™ Total Shoulder Arthroplasty (anatomic) — part of the InSet™ platform; positioned as a complementary solution to the reverse system for surgeons using a common philosophy and instrumentation. Indications Rotator Cuff Primary indication: gross rotator cuff deficiency with severe arthropathy and/or previously failed shoulder arthroplasty with gross rotator cuff deficiency; functional deltoid required. Indicated for primary or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency; patient must be anatomically and structurally suited to receive the implants. Glenoid baseplate: cementless application with screw fixation; humeral stem: press-fit or cemented. Contraindications Absolute: active infection, sepsis, osteomyelitis. Relative: uncooperative patient or neurologic disorders precluding compliance; osteoporosis; metabolic disorders impairing bone formation; osteomalacia; distant foci of infection; rapid joint destruction/marked bone loss/resorption on radiographs; lack of quality bone or skeletal immaturity; metal allergy or sensitivity; infection at or near the implant site. Anatomy Osteology Glenoid vault and scapular pillar orientation guide baseplate seating and screw trajectory; inferior glenoid and scapular neck morphology influence impingement risk and fixation strategies (General surgical considerations). Proximal humeral canal geometry and metaphyseal bone quality affect stem press-fit vs. cement choice and tray seating (General surgical considerations). Muscles Reverse constructs are deltoid-dependent for elevation; residual cuff (notably subscapularis and teres minor) may influence stability and rotation (General surgical considerations). Ligaments Coracoacromial arch can contribute to superior stability after reverse arthroplasty; preserve when possible to reduce anterosuperior escape risk (General surgical considerations). Nerves Axillary nerve courses inferior to the glenoid and around the surgical neck; identify/protect during deltopectoral exposure and inferior capsular releases; musculocutaneous nerve proximity mandates careful retractor placement medially (General surgical considerations). Blood supply Ascending branch of the anterior circumflex humeral artery (ACHA) and arcuate artery supply the humeral head; respect during subscapularis management and humeral preparation to mitigate bleeding and promote healing (General surgical considerations). Approach Standard deltopectoral approach with cephalic vein preservation preferred; use blunt Hohmanns and inferior glenoid retractors judiciously; continuously identify/protect the axillary nerve during inferior capsular work and humeral preparation (General surgical considerations). Technique Pre-operative: ensure familiarity with the specific operative technique; confirm indications/contraindications; verify packaging integrity and have an appropriate size range available. Glenoid preparation: expose glenoid, prepare surface for baseplate; baseplate is intended for cementless application with adjunctive screw fixation. Baseplate fixation: utilize a central compression screw and peripheral screws as indicated; adhere to system-specific locking hardware and torque recommendations (follow surgical technique). Glenosphere assembly and replacement rule: after impaction, if repositioning of the glenosphere is needed, replace both the glenosphere and the glenoid baseplate with new components. Humeral side: choose stem fixation based on bone quality and surgeon preference — press-fit or cemented are both permitted. Bearing/tray assembly: use only compatible InSet™ Reverse components; handle articulating and locking surfaces with clean gloves; remove all debris and bone chips before closure to limit wear and instability. Intra-op handling warnings: avoid scratches/dents and misalignment that can increase wear, corrosion, or fatigue fracture; do not modify implants; implant trials are not to be implanted. Post-op considerations: communicate activity limitations and the importance of rehabilitation and follow-up; excessive activity, trauma, or excessive weight may contribute to loosening, fracture, and wear. Technical specifications Components: humeral stem, modular tray, UHMWPE bearing, glenoid baseplate, locking nut/set screw, compression screw, supplementary screws, and metal glenosphere. Materials/standards: titanium alloy (humeral stem, baseplate, modular tray, locking/set screw, compression and supplementary screws) per ASTM F136; porous coating of commercially pure titanium (CP-Ti) per ASTM F67 on stem and baseplate (grit-blasted baseplate option also offered); glenosphere cobalt-chromium alloy per ASTM F1537; bearing UHMWPE per ASTM F648; instruments stainless steel and medical-grade plastics. Fixation: baseplate indicated for cementless application with screw fixation; humeral stem may be implanted by press-fit or with bone cement. Screw sizes and locking hardware: peripheral screws 4.5 mm; central screw 6.0 mm; baseplate set screw and glenosphere locking bolts are part of the system’s locking hardware. Sterilization & packaging (implants): implants are individually packaged and supplied sterile; all metal implants sterilized by gamma irradiation; all polyethylene implants sterilized using ethylene oxide (EtO); check expiration (“use-by”) date; never re-sterilize; single-use only. MRI safety: the system has not been evaluated for MRI safety or compatibility; risks (heating, migration, artifact) are unknown. Instrumentation & supplementary screws: provided non-sterile; must be steam-sterilized prior to use. Steam sterilization parameters (wrap with FDA-cleared wrap): pre-vacuum steam at 270 °F (132 °C) for 4 minutes with 60-minute dry time; flash sterilization not recommended. Storage/handling (implants): store in original sealed packaging; inspect labeling/packaging integrity before use; reject if packaging is damaged. Key warnings/precautions: improper selection/positioning/alignment/fixation may reduce service life; debris left in the joint may cause instability, pain, restricted motion, or premature wear; activity/weight/trauma can contribute to loosening, fracture, and wear; patient compliance with rehabilitation and follow-up is essential; Rx-only (U.S. federal law restricts to sale by or on the order of a physician).