# K133834: Depuy Global Unite Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy (Ireland)
- Decided: Apr 3, 2014 after 107 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K911686 (1991). 6 ancestors in all.
21 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011047: Global Advantage Humeral Stem with Porocoat, DePuy Orthopaedics, Inc. (2001) Summary page 7.
- K992065: Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head, DePuy Orthopaedics, Inc. (1999) Summary page 7.

## Most influential descendants
- K161863: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA) (2016), 13 descendants of its own
- K170748: GLOBAL UNITE Platform Shoulder System (2018), 10 descendants of its own
- K172210: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) (2017), 10 descendants of its own
- K181742: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) (2018), 9 descendants of its own
- K183039: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) (2019), 8 descendants of its own

## Recalls of this device
- Nov 28, 2017 · Class II · Z-1012-2018: The screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body was inverted during assembly to the body, which will cause the humeral stem to sit proud and may cause surgi

## Indications for use
The Global UNITE Shoulder System 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 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/K133834
Methodology: https://510kreport.com/methodology