# K101996: Depuy Global Unite Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy (Ireland)
- Decided: Dec 15, 2010 after 153 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: 7 generations back to K911686 (1991). 21 ancestors in all.
16 later devices descend from it; 4 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063652: Global AP Porous Coated Humeral Stem, DePuy Orthopaedics, Inc. (2007) Summary page 4.
- K060874: Depuy Global AP Shoulder System, DePuy Orthopaedics, Inc. (2006) Summary page 4.
- K071379: Delta Xtend Reverse Shoulder Modular Stem, DePuy Orthopaedics, Inc. (2007) Summary page 4.

## Most influential descendants
- K170748: GLOBAL UNITE Platform Shoulder System (2018), 10 descendants of its own
- K170910: Medacta Anatomic Shoulder Prosthesis (2017), 8 descendants of its own
- 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
- K180089: Medacta Shoulder System Short Humeral Diaphysis (2018), 3 descendants 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 humeral stems, suture collars, epiphyseal components and humeral heads are intended for cemented or uncemented total shoulder or hemi-shoulder replacement in treatment of the following: 1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis 2. Fracture-dislocations 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 3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component) Hemi-shoulder replacement is also indicated for: 1. Ununited humeral head fractures 2. Avascular necrosis of the humeral head 3. Deformity and/or limited motion When used in a total shoulder replacement, the Global UNITE implants are to be used with DePuy glenoids. The glenoids are for cemented use only. When well-fixed, the Global UNITE humeral stems, in conjunction with existing Delta Xtend epiphyseal components, are also indicated for conversion to a reverse, 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. The Delta Xtend metaglene component is HA-coated and is intended for uncemented use with the addition of screws for fixation. The Delta Xtend epiphyseal components are HA-coated and are intended for uncemented use.

Source page: https://510kreport.com/device/K101996
Methodology: https://510kreport.com/methodology