510(k) · Cleared
Recalled · Class II · 2017Depuy Global Unite Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy (Ireland) · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Apr 3, 2014 as substantially equivalent to K011047 (DePuy Orthopaedics, Inc., 2001) and 1 other predicate after a 107-day review. Its family tree reaches back 3 generations to 1991. 21 later devices descend from it. It has been recalled once.
- Decided
- Apr 3, 2014
- Review
- 107 days
- Class
- Class II
- Product code
- KWS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K911686 (1991). 6 ancestors in all. 21 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 2 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 1 generation backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- This deviceK133834 Depuy Global Unite Shoulder SystemDepuy (Ireland) · 2014
- Descendant · cites it directly · 13 of its ownK161863 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2016
- Descendant · cites it directly · 10 of its ownK170748 GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC · 2018 · Recalled
- Descendant · 2 generations on · 10 of its ownK172210 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker Trauma AG · 2017
- Descendant · 3 generations on · 9 of its ownK181742 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2018
- Descendant · 4 generations on · 8 of its ownK183039 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder…Stryker GmbH · 2019
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH · 2016 · cites it directly13descendants
- K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC · 2018 · cites it directly10descendants
- K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG · 2017 · 2 generations on10descendants
- K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH · 2018 · 3 generations on9descendants
- K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH · 2019 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −2 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −1 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| 0 (this device) | K133834 | Depuy Global Unite Shoulder System | Depuy (Ireland) | 2014 | — |
| +1 | K161863 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder… | Stryker GmbH | 2016 | — |
| +1 | K170748 | GLOBAL UNITE Platform Shoulder System | Depuy Ireland UC | 2018 | 8 |
| +2 | K172210 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder… | Stryker Trauma AG | 2017 | — |
| +3 | K181742 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder… | Stryker GmbH | 2018 | — |
| +4 | K183039 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder… | Stryker GmbH | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 5 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K011047 | Global Advantage Humeral Stem with PorocoatSummary page 7…believes the subject Global UNITE Shoulder System is substantially equivalent to the previously cleared DePuy Global Advantage Shoulder System, cleared in K992065 and KO011047. K133834 Page 5 of 5 PERFORMANCE DATA The following tests were performed (per FDA’s Guidance for Industry and F… | 2001 |
| * | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric HeadSummary page 7…design, DePuy believes the subject Global UNITE Shoulder System is substantially equivalent to the previously cleared DePuy Global Advantage Shoulder System, cleared in K992065 and KO011047. K133834 Page 5 of 5 PERFORMANCE DATA The following tests were performed (per FDA’s Guidance for I… | 1999 |
What descends from it? (21)
See all 213 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 28, 2017 | Class II | Z-1012-2018 | Employee error | 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 surgical delays. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K161863 (Stryker GmbH, 2016) has gone furthest, with 13 descendants of its own.
- 4 other devices also cite its predicate K011047.
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. 2014, 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 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…
Read the full statement (246 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K133834 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133834: Depuy Global Unite Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133834
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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