510(k) · Cleared
ClearedGlobal Shoulder and Delta CTA systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Lnc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Apr 2, 2021 as substantially equivalent to K984541 (DePuy Orthopaedics, Inc., 1999) and 18 other predicates after a 151-day review. Its family tree reaches back 7 generations to 1980.
- Decided
- Apr 2, 2021
- Review
- 151 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 19
Its longest line of descent runs back 7 generations to K800494 (1980). 50 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 6 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- 5 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
- 4 generations backK010827 Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc. · 2001 · Recalled
- 3 generations backK031971 Global Cap Resurfacing Replacement ShoulderDePuy Orthopaedics, Inc. · 2003
- 2 generations backK051843 Copeland Eas Humeral Resurfacing HeadsBiomet, Inc. · 2005 · Recalled
- 1 generation backK080990 Depuy Global C.AP. Cta Resurfacing ShoulderDePuy Orthopaedics, Inc. · 2008
- This deviceK203230 Global Shoulder and Delta CTA systemsDepuy Lnc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K800494 | New Jersey Hemiarthroplasty Sholder Pros | Depuy, Inc. | 1980 | — |
| −6 | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| −5 | K002998 | Biomet BI-Polar Shoulder System | Biomet, Inc. | 2000 | 1 |
| −4 | K010827 | Copeland MB/HA Resurfacing Humeral Heads | Biomet Orthopedics, Inc. | 2001 | 1 |
| −3 | K031971 | Global Cap Resurfacing Replacement Shoulder | DePuy Orthopaedics, Inc. | 2003 | — |
| −2 | K051843 | Copeland Eas Humeral Resurfacing Heads | Biomet, Inc. | 2005 | 1 |
| −1 | K080990 | Depuy Global C.AP. Cta Resurfacing Shoulder | DePuy Orthopaedics, Inc. | 2008 | — |
| 0 (this device) | K203230 | Global Shoulder and Delta CTA systems | Depuy Lnc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 5 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KWS device
- #1 K220847 AETOS Shoulder Systemscore 21.1 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (19)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K984541 | Global FX Humeral Stem, Global Advantage Humeral HeadSummary page 18…ICE(S) Table 5- 9 Predicate Devices: Global Shoulder - GLOBAL ADVANTAGE Trade Name: GLOBAL ADVANTAGE® K984541 K992065 K000575 K011047 Global… | 1999 |
| * | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric HeadSummary page 18…Table 5- 9 Predicate Devices: Global Shoulder - GLOBAL ADVANTAGE Trade Name: GLOBAL ADVANTAGE® K984541 K992065 K000575 K011047 Global… | 1999 |
| * | K000575 | Global Advantage Extended Humeral HeadSummary page 18…te Devices: Global Shoulder - GLOBAL ADVANTAGE Trade Name: GLOBAL ADVANTAGE® K984541 K992065 K000575 K011047 Global Advantage… | 2000 |
| * | K011047 | Global Advantage Humeral Stem with PorocoatSummary page 18…lder - GLOBAL ADVANTAGE Trade Name: GLOBAL ADVANTAGE® K984541 K992065 K000575 K011047 Global Advantage… | 2001 |
| * | K011099 | Global FX Porous-Coated Humeral StemSummary page 19…0 Predicate Devices: Global Shoulder - GLOBAL FX Trade Name: Global FX K984541 K011099 Global FX Porous-coated Global FX Porous-coated Device Name:… | 2001 |
| * | K033516 | Depuy Global Cap HA Resurfacing Shoulder Humeral HeadsSummary page 19…0 Table 5- 11 Predicate Devices: Global Shoulder - GLOBALTM CAP Trade Name: Global CAP K033516 K080990 DePuy Global CAP™ HA… | 2003 |
| * | K080990 | Depuy Global C.AP. Cta Resurfacing ShoulderSummary page 19…- 11 Predicate Devices: Global Shoulder - GLOBALTM CAP Trade Name: Global CAP K033516 K080990 DePuy Global CAP™ HA… | 2008 |
| * | K981487 | Depuy Global Shoulder GlenoidSummary page 19…Table 5- 12 Predicate Devices: Global Shoulder - Global APG Trade Name: Global APG K981487 K052472 DePuy Global Shoulder… | 1998 |
| * | K052472 | Depuy Global Shoulder Crosslink GlenoidSummary page 19…Predicate Devices: Global Shoulder - Global APG Trade Name: Global APG K981487 K052472 DePuy Global Shoulder… | 2005 |
| * | K060874 | Depuy Global AP Shoulder SystemSummary page 20…Global Shoulder and Delta CTA MRI Table 5- 13 Predicate Devices: Global Shoulder - GLOBAL AP Trade Name: Global AP K060874 K063652 K082715 DePuy Global AP™ Global… | 2006 |
| * | K063652 | Global AP Porous Coated Humeral StemSummary page 20…A MRI Table 5- 13 Predicate Devices: Global Shoulder - GLOBAL AP Trade Name: Global AP K060874 K063652 K082715 DePuy Global AP™ Global AP Porous Coated Humeral… | 2007 |
| * | K082715 | Depuy Global AP Cta Humeral HeadSummary page 20…5- 13 Predicate Devices: Global Shoulder - GLOBAL AP Trade Name: Global AP K060874 K063652 K082715 DePuy Global AP™ Global AP Porous Coated Humeral DePuy Global AP CTA Device Name:… | 2008 |
| * | K092122 | Global Shoulder Steptech Anchor Peg GlenoidSummary page 20…dicate Devices: Global Shoulder – Global StepTech Trade Name: GLOBAL® STEPTECH® K092122 Global Shoulder StepTech Anchor Device… | 2009 |
| * | K914000 | Global (TM) Total Shoulder W/Dupont Enhanced UhmwpeSummary page 20…Table 5- 15 Predicate Devices: Global Shoulder - Global Shoulder Trade Name: GLOBAL® SHOULDER K914000; K905786 K052472 Device Name Global™ Total… | 1991 |
| * | K905786 | Global Total ShoulderSummary page 20…Table 5- 15 Predicate Devices: Global Shoulder - Global Shoulder Trade Name: GLOBAL® SHOULDER K914000; K905786 K052472 Device Name Global™ Total D… | 1991 |
| * | K021478 | Delta ShoulderSummary page 21…and Delta CTA MRI Table 5- 16 Predicate Devices: DELTA CTATM Trade Name: DELTA CTA; IFU: W90926 and W90916 K021478 K050315 K062116 K122442… | 2003 |
| * | K050315 | Delta Humeral CupsSummary page 21…Table 5- 16 Predicate Devices: DELTA CTATM Trade Name: DELTA CTA; IFU: W90926 and W90916 K021478 K050315 K062116 K122442 Delta Rev… | 2005 |
| * | K062116 | Delta Cta Reverse Shoulder System Humeral HeadsSummary page 21…Table 5- 16 Predicate Devices: DELTA CTATM Trade Name: DELTA CTA; IFU: W90926 and W90916 K021478 K050315 K062116 K122442 Delta Reverse… | 2006 |
| * | K122442 | Depuy Cta Reverse Shoulder SystemSummary page 21…Devices: DELTA CTATM Trade Name: DELTA CTA; IFU: W90926 and W90916 K021478 K050315 K062116 K122442 Delta Reverse… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 41 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 12 of the 50 ancestors have a recall of any class.
- 9 other devices also cite its predicate K984541.
How does its category compare?
All KWS devicesKWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · KWS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWS
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWS
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWS
2,281in 2025
MAUDE reports naming product code KWS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 21 | 158 |
| 2008 | 4 | 37 | 29 | 238 |
| 2009 | 4 | 108 | 0 | 294 |
| 2010 | 7 | 33 | 10 | 393 |
| 2011 | 11 | 90 | 11 | 486 |
| 2012 | 7 | 86 | 10 | 542 |
| 2013 | 12 | 120 | 0 | 818 |
| 2014 | 7 | 89 | 1 | 1,066 |
| 2015 | 8 | 129 | 0 | 1,170 |
| 2016 | 10 | 114 | 1 | 970 |
| 2017 | 7 | 120 | 4 | 1,681 |
| 2018 | 4 | 152 | 1 | 1,545 |
| 2019 | 9 | 106 | 2 | 1,728 |
| 2020 | 3 | 98 | 5 | 1,567 |
| 2021 | 5 | 151 | 0 | 1,358 |
| 2022 | 5 | 158 | 0 | 1,268 |
| 2023 | 4 | 250 | 2 | 1,750 |
| 2024 | 2 | — | 0 | 2,122 |
| 2025 | 3 | 97 | 0 | 2,281 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (1,288 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203230 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203230: Global Shoulder and Delta CTA systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203230
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026