# K203230: Global Shoulder and Delta CTA systems

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Lnc.
- Decided: Apr 2, 2021 after 151 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- 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: 7 generations back to K800494 (1980). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984541: Global FX Humeral Stem, Global Advantage Humeral Head, DePuy Orthopaedics, Inc. (1999) Summary page 18.
- K992065: Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head, DePuy Orthopaedics, Inc. (1999) Summary page 18.
- K000575: Global Advantage Extended Humeral Head, DePuy Orthopaedics, Inc. (2000) Summary page 18.
- K011047: Global Advantage Humeral Stem with Porocoat, DePuy Orthopaedics, Inc. (2001) Summary page 18.
- K011099: Global FX Porous-Coated Humeral Stem, DePuy Orthopaedics, Inc. (2001) Summary page 19.
- K033516: Depuy Global Cap HA Resurfacing Shoulder Humeral Heads, DePuy Orthopaedics, Inc. (2003) Summary page 19.
- K080990: Depuy Global C.AP. Cta Resurfacing Shoulder, DePuy Orthopaedics, Inc. (2008) Summary page 19.
- K981487: Depuy Global Shoulder Glenoid, DePuy Orthopaedics, Inc. (1998) Summary page 19.
- K052472: Depuy Global Shoulder Crosslink Glenoid, DePuy Orthopaedics, Inc. (2005) Summary page 19.
- K060874: Depuy Global AP Shoulder System, DePuy Orthopaedics, Inc. (2006) Summary page 20.
- K063652: Global AP Porous Coated Humeral Stem, DePuy Orthopaedics, Inc. (2007) Summary page 20.
- K082715: Depuy Global AP Cta Humeral Head, DePuy Orthopaedics, Inc. (2008) Summary page 20.
- K092122: Global Shoulder Steptech Anchor Peg Glenoid, DePuy Orthopaedics, Inc. (2009) Summary page 20.
- K914000: Global (TM) Total Shoulder W/Dupont Enhanced Uhmwpe, Depuy, Inc. (1991) Summary page 20.
- K905786: Global Total Shoulder, Depuy, Inc. (1991) Summary page 20.
- K021478: Delta Shoulder, Depuy, Inc. (2003) Summary page 21.
- K050315: Delta Humeral Cups, DePuy Orthopaedics, Inc. (2005) Summary page 21.
- K062116: Delta Cta Reverse Shoulder System Humeral Heads, DePuy Orthopaedics, Inc. (2006) Summary page 21.
- K122442: Depuy Cta Reverse Shoulder System, Depuy France (2012) Summary page 21.

## Indications for use
The DePuy GLOBAL ADVANTAGE Shoulder Systems The DePuy GLOBAL ADVANTAGE Shoulder Systems is indicated for use in total or hemi-shoulder replacement for the treatment of: 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). The DePuy GLOBAL ADVANTAGE Shoulder System is also indicated for hemi-shoulder replacement for the treatment of: 1. Ununited humeral head fractures; 2. Avascular necrosis of the humeral head. GLOBAL ADVANTAGE CTA Humeral Heads The DePuy GLOBAL ADVANTAGE CTA Humeral Heads are indicated only for hemi-shoulder replacement in patients with rotator cuff tears. The DePuy GLOBAL ADVANTAGE CTA Humeral Heads can be used with the GLOBAL FX and GLOBAL ADVANTAGE Humeral Stems in hemi-shoulder replacement in patients with rotator cuff tears. GLOBAL ADVANTAGE Shoulder Systems Fixation Methods The DePuy GLOBAL ADVANTAGE Systems are indicated for the following fixation methods: POROCOAT™ Porous-Coated Components - Porocoat porous-coated humeral stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating. Cemented Components - Humeral Stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement. Press-fit or Cemented Components - Humeral stem prostheses without porous coating and labeled "For press-fit or cemented use only" are indicated for press-fit uncemented use or for use with bone cement. The DePuy GLOBAL FX Shoulder System is indicated only for hemi-shoulder replacement for the treatment of: 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); 4. Ununited humeral head fractures; 5. Avascular necrosis of the humeral head. GLOBAL FX Shoulder Systems Fixation Methods The DePuy GLOBAL FX Shoulder System is indicated for the following fixation methods: • POROCOAT™ Porous-Coated Components - Porocoat porous-coated humeral stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating. • Cemented Components - Humeral Stem and Glenoid components labeled “For cemented use only” are indicated only for use with bone cement. • Press-fit or Cemented Components - Humeral stem prostheses without porous coating and labeled “For press-fit or cemented use only” are indicated for press-fit uncemented use or for use with bone cement. GLOBAL™ CAP The DePuy GLOBAL™ CAP Resurfacing Shoulder Humeral Heads are intended as a total or hemi-shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. This device is designed to increase shoulder mobility by: reducing pain; restoring alignment; restoring flexion and extension movement; and resisting dislocation. The DePuy GLOBAL™ CAP Resurfacing Shoulder Humeral Heads are indicated for use as a replacement of shoulder joints disabled by rheumatoid arthritis with pain, non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis), deformity and/or limited motion, fractures of the humeral head and traumatic arthritis. The DePuy GLOBAL™ CAP Resurfacing Shoulder Humeral Heads are intended for uncemented use only. GLOBAL™ CAP CTA™ The DePuy GLOBAL ™ CAP CTA Resurfacing Shoulder is indicated only for hemi-shoulder replacement in patients with rotator cuff tears and arthritis. Specific indications include: 1. Rotator cuff tear arthropathy. 2. Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate. The DePuy GLOBAL ™CAP CTA Resurfacing Shoulder Humeral Heads are intended for uncemented use only. The Glenoid is intended for use in total shoulder replacement surgery for patients suffering from: 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 communited, 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). Glenoid components are intended for cemented use only. The DePuy GLOBAL AP Shoulder System The DePuy GLOBAL AP Shoulder System is indicated for use in total or hemi-shoulder replacement for the treatment of: 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). The DePuy GLOBAL AP Shoulder Systems is also indicated for hemi-shoulder replacement for the treatment of: 1. Ununited humeral head fractures; 2. Avascular necrosis of the humeral head. GLOBAL AP™ CTA Humeral Heads The DePuy GLOBAL AP CTA Humeral Heads are indicated only for hemi-shoulder replacement in patients with rotator cuff tears. The GLOBAL AP CTA Humeral Head can be used with the GLOBAL AP Humeral Stem in hemi-shoulder replacement in patients with rotator cuff tears. GLOBAL AP™ Shoulder Systems Fixation Methods The DePuy GLOBAL AP Shoulder Systems are indicated for the following fixation methods: POROCOAT™ Porous-Coated Components - Porocoat porous-coated humeral stem prostheses are indicated for cemented or uncemented use with fixation provided by biological tissue ingrowth into the porous coating. Cemented Components - Humeral Stem and Glenoid components labeled "For cemented use only" are indicated only for use with bone cement. Press-fit or Cemented Components - Humeral stem prostheses without porous coating and labeled "For press-fit or cemented use only" are indicated for press-fit uncemented use or for use with bone cement. The StepTech Anchor Peg Glenoid is intended for use in total shoulder replacement surgery for patients suffering from: 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 communited, 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). Glenoid components are intended for cemented use only. The Glenoid is intended for use in total shoulder replacement surgery for patients suffering from: 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 surfaces are severely communited, 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). Glenoid components are intended for cemented use only. The DELTA CTATM Reverse Shoulder Prosthesis is indicated for use in: 1. Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient joint. 2. The DELTA CTATM hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for revision surgery in cases with insufficient glenoid bone stock. 3. 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. For US use only: All components are intended for cemented use only

Source page: https://510kreport.com/device/K203230
Methodology: https://510kreport.com/methodology