# K212710: GLOBAL UNITE™ Platform Shoulder System

- Pathway: 510(k) (Special)
- Applicant: Depuy Ireland UC
- Decided: Sep 15, 2021 after 20 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K911686 (1991). 155 ancestors in all.
No later device cites it as a predicate yet.
1 of 156 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202098: GLOBAL UNITE™ Platform Shoulder System, Depuy Ireland UC (2020) Summary page 5.
- K101996: Depuy Global Unite Shoulder System, Depuy (Ireland) (2010) Summary page 5.
- K170748: GLOBAL UNITE Platform Shoulder System, Depuy Ireland UC (2018) Summary page 5.

## Indications for use
Section 1: Applicable for the GLOBAL UNITE™ Platform Shoulder System with GLOBAL UNITE™ Standard or Revision/Long Humeral Stem Implants The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total or hemi-shoulder arthroplasty in treatment of the following: * A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis * Fracture of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory » Irreducible 3- and 4-part fractures of the proximal humerus * Ununited humeral head fractures * Avascular necrosis of the humeral head * Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary component) Hemi-shoulder arthroplasty is also indicated for: * Deformity and/or limited motion The GLOBAL UNITE™ Reverse Fracture Epiphyseal Component, in conjunction with components from the existing DELTA XTEND™ Reverse Shoulder System and GLOBAL UNITE Platform Shoulder System, is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. It is intended for cemented or uncemented reverse shoulder arthroplasty in treatment of the following: * Fracture of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory » Irreducible 3- and 4-part fractures of the proximal humerus * Ununited humeral head fractures The GLOBAL UNITE Reverse Fracture Epiphyseal Component is only intended for use in the treatment of proximal humeral fractures. Bone preparation instrumentation has not been developed to accommodate its use in a non-fracture press-fit application. GLOBAL UNITE Humeral Stems, in conjunction with existing DELTA XTEND Epiphyseal Components, are indicated for use in reverse shoulder arthroplasty in treatment of a grossly deficient rotator cuff joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. When used in a total shoulder arthroplasty, the GLOBAL UNITE™ Implants are to be used with DePuy glenoid components. The glenoid components are for cemented use only. GLOBAL UNITE Humeral Implants are for cemented or uncemented use. When used in a reverse shoulder arthroplasty, the GLOBAL UNITE and DELTA XTEND™ Humeral Implants are to be used with the HA-coated DELTA XTEND Metaglene Devices. The metaglene implants are intended for uncemented use only with additional screw fixation. The HA-coated DELTA XTEND Humeral Implants are intended for uncemented use only. Porous-coated epiphyses are intended for cemented or uncemented use. GLOBAL UNITE Humeral Implants are for cemented or uncemented use. Section 2: Applicable for the GLOBAL UNITE™ Platform Shoulder System with GLOBAL UNITE™ Short Humeral Stem Implants GLOBAL UNITE Short Humeral Stem Implants are for uncemented use only. The GLOBAL UNITE Platform Shoulder System with Short Humeral Stem is intended for uncemented total or hemi-shoulder arthroplasty in treatment of the following: * A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis » Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component) Hemi-shoulder arthroplasty is also indicated for: * Deformity and/or limited motion GLOBAL UNITE Short Humeral Stems, in conjunction with existing DELTA XTEND Epiphyseal Components, are indicated for use in reverse shoulder arthroplasty in treatment of a grossly deficient rotator cuff joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. When used in a total shoulder arthroplasty, the GLOBAL UNITE Implants are to be used with DePuy glenoid components. The glenoid components are for cemented use only. When used in a reverse shoulder arthroplasty, the GLOBAL UNITE and DELTA XTEND™ Humeral Implants are to be used with the HA-coated DELTA XTEND Metaglene Devices. The metaglene implants are intended for uncemented use only with additional screw fixation. The HA-coated DELTA XTEND Humeral Implants are intended for uncemented use only. Porous-coated epiphyses are intended for cemented or uncemented use. GLOBAL UNITE Short Humeral Stem Implants are for uncemented use only.

Source page: https://510kreport.com/device/K212710
Methodology: https://510kreport.com/methodology