# K170748: GLOBAL UNITE Platform Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Jan 11, 2018 after 307 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K911686 (1991). 41 ancestors in all.
10 later devices descend from it; 5 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052906: Zimmer Trabecular Metal Reverse Shoulder System, Zimmer, Inc. (2005) Summary page 5.
- K060704: Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM, Zimmer, Inc. (2006) Summary page 5.
- K101996: Depuy Global Unite Shoulder System, Depuy (Ireland) (2010) Summary page 5.
- K133834: Depuy Global Unite Shoulder System, Depuy (Ireland) (2014) Summary page 5.

## Most influential descendants
- K191433: AGILON® XO Shoulder Replacement System (2020), 3 descendants of its own
- K192855: DELTA XTEND (TM) Reverse Shoulder System (2020), 3 descendants of its own
- K231657: AGILON® XO Shoulder Replacement System (2024), 2 descendants of its own
- K241944: AGILON® XO Shoulder Replacement System (2025), 1 descendant of its own
- K202098: GLOBAL UNITE™ Platform Shoulder System (2020), 1 descendant of its own

## Recalls of this device
- Dec 7, 2021 · Class II · Z-0484-2022: Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
- Dec 7, 2021 · Class II · Z-0485-2022: Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
- Dec 7, 2021 · Class II · Z-0486-2022: Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
- Dec 7, 2021 · Class II · Z-0487-2022: Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
- Dec 7, 2021 · Class II · Z-0490-2022: Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
- Dec 7, 2021 · Class II · Z-0483-2022: Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
- Dec 7, 2021 · Class II · Z-0488-2022: Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
- Dec 7, 2021 · Class II · Z-0489-2022: Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

## Indications for use
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 validated 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 reverse 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. GLOBAL UNITE humeral implants are for cemented or uncemented use. The DELTA XTEND epiphyseal components are HA-coated and are intended for uncemented use.

Source page: https://510kreport.com/device/K170748
Methodology: https://510kreport.com/methodology