Total Shoulder Prosthesis

The Total Shoulder Replacement System is an Orthopedic Joint Replacement System designed for use in Shoulder Arthroplasty / Total Shoulder Replacement procedures when the orthopedic surgeon determines that joint replacement is appropriate for the clinical case.

The system is based on reconstruction of the anatomical and mechanical relationship between the Proximal Humerus and the Glenoid Side of the shoulder using prosthetic components designed to function together as an integrated Shoulder Reconstruction Construct.

The system includes a Humeral Prosthetic Component that extends into the Humeral Canal and incorporates proximal geometry designed to support the compatible articulating component. Together with the other components of the Shoulder Prosthesis, it contributes to formation of an Artificial Shoulder Articulation according to the approved system design.

The size, position, and orientation of the components are determined based on Preoperative Planning, Bone Anatomy, Bone Stock, Soft-Tissue Condition, Component Positioning, and Intraoperative Trialing.

According to the supplied product table, the system is identified as:

Total Shoulder Prosthesis

and carries the product code:

AMS 104.130.000

This code serves as the primary reference for identifying the Shoulder Replacement System within the product catalogue and for Inventory Management and Procurement processes.

What Is a Total Shoulder Prosthesis?

A Total Shoulder Prosthesis is a joint replacement system used to reconstruct the shoulder joint by replacing damaged articular surfaces with compatible prosthetic components.

In Shoulder Arthroplasty, the relationship between the following components is generally reconstructed:

Humeral Component ↔ Shoulder Articulation ↔ Glenoid Component

The Humeral Component forms the humeral side of the artificial joint, while the Glenoid Component, or corresponding acetabular-side component, completes the glenoid side according to the system design.

The objective of the system is to create a Prosthetic Shoulder Joint that is mechanically compatible with the surgical plan and the patient’s anatomy.

System Components

Important: The supplied product table identifies the system as a Total Shoulder Prosthesis under one primary product code but does not provide a detailed list of individual component codes or sizes. Therefore, the following components are described using general industry terminology without assuming specifications that are not provided.

1. Humeral Stem

The Humeral Stem is the longitudinal portion of the implant inserted into the Humeral Intramedullary Canal after preparation of the Proximal Humerus according to the approved Surgical Technique.

It represents one of the principal fixation elements on the humeral side of the Shoulder Prosthesis.

2. Proximal Humeral Body

The proximal portion of the stem, designed to correspond with the Proximal Humerus and function as an interface between the Intramedullary Stem and the superior articulating component.

3. Humeral Head / Articular Component

The articulating component representing the prosthetic humeral head and functioning with the corresponding glenoid-side component to create the Shoulder Bearing Interface.

The diameter, material, and modularity of the head are not specified in the current product table.

4. Glenoid Component

In Total Shoulder Replacement Systems, the Glenoid Component forms the glenoid side of the artificial joint and articulates with the Humeral Head.

However, its presence as a separate component within the current product package and its specific technical characteristics are not confirmed in the supplied table. These details should therefore be verified using the approved Technical Datasheet.

5. Modular Connection Interface

The proximal geometry of the implant appears to allow connection between system components; however, the specific Taper Type or Locking Mechanism is not defined in the available data.

Product Application

The Total Shoulder Prosthesis is used in:

Shoulder Arthroplasty / Total Shoulder Replacement

The system is selected when the orthopedic surgeon determines that reconstruction of the shoulder joint using Prosthetic Components is appropriate according to the official clinical indications.

General surgical planning and use may include:

1. Preoperative Imaging & Planning
2. Evaluation of Proximal Humeral Anatomy
3. Evaluation of Glenoid Anatomy
4. Assessment of Bone Stock
5. Determination of Component Size and Orientation
6. Preparation of the Humeral Canal
7. Preparation of the glenoid side according to the system design
8. Trial Reduction
9. Evaluation of:
   • Joint Stability
   • Component Position
   • Soft-Tissue Tension
   • Range of Motion
   • Shoulder Alignment
10. Placement of the Final Components according to the approved Surgical Technique

The system should be used by a Qualified Orthopedic Surgeon in accordance with the approved IFU.

Key Benefits

Complete Shoulder Reconstruction Concept

Provides an integrated concept for reconstruction of the shoulder joint within Shoulder Arthroplasty procedures.

Humeral Prosthetic Reconstruction

The system incorporates a Humeral Component designed to reconstruct the humeral side of the artificial shoulder joint.

Anatomical Planning Support

The system supports planning according to:

• Proximal Humeral Anatomy
• Glenoid Anatomy
• Bone Stock
• Component Position
• Soft-Tissue Balance

Intraoperative Trialing

Shoulder arthroplasty systems allow Trialing to assess the Joint Construct before placement of the final components.

Component-Based Reconstruction

The system is based on compatible Prosthetic Components designed to function together within a Shoulder Replacement Construct.

Clear System Identification

A clearly defined primary system code facilitates:

• Product Identification
• Procurement
• Surgical Set Preparation
• Inventory Management
• Stock Control

Technical Specifications

Product Code	Product Description	Product Type
AMS 104.130.000	Total Shoulder Prosthesis	Total Shoulder Replacement System

Technical Overview

Product Name: Total Shoulder Prosthesis
System Name: Total Shoulder Replacement System
Product Code: AMS 104.130.000
Product Category: Orthopedic Joint Replacement System
Anatomical Application: Shoulder Joint
Procedure Category: Shoulder Arthroplasty / Total Shoulder Replacement
Primary Anatomical Interface: Proximal Humerus / Glenoid
Visible Primary Component: Humeral Prosthetic Component
Stem Concept: Intramedullary Humeral Stem
Functional Concept: Prosthetic Shoulder Articulation
Selection Method: Preoperative Planning & Intraoperative Assessment
Identification: AMS 104.130.000

Product Features

• Total Shoulder Replacement System
• Designed for use in Shoulder Arthroplasty
• Based on prosthetic reconstruction of the shoulder joint
• Incorporates a Humeral Stem Component within the system
• Designed to extend within the Humeral Intramedullary Canal
• Provides proximal geometry designed for the articulating portion of the Shoulder Construct
• Functions within a compatible system to reconstruct the Shoulder Articulation
• Supports Preoperative Planning
• Allows Intraoperative Trialing and assessment of the final construct
• Supports evaluation of Component Position and Joint Stability
• Suitable for shoulder joint reconstruction according to the anatomy and requirements of the case
• Clear system code: AMS 104.130.000
• Facilitates System Identification within the product catalogue
• Supports Surgical Set Preparation
• Suitable for organized Inventory Management, Procurement, and Stock Control