510(k) · Cleared
Recalled · 2008Modification to Depuy Delta Xtend Reverse Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Jun 30, 2008 as substantially equivalent to K062250 (DePuy Orthopaedics, Inc., 2007) and 1 other predicate after a 21-day review. Its family tree reaches back 8 generations to 1991. 109 later devices descend from it. It has been recalled 8 times.
- Decided
- Jun 30, 2008
- Review
- 21 days
- Class
- Class II
- Product code
- KWS
- Recalls
- 8
- Predicates
- 2
Its longest line of descent runs back 8 generations to K911686 (1991). 15 ancestors in all, the oldest K800494 (1980). 109 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 7 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 6 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 5 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 4 generations backK062116 Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006
- 3 generations backK062250 Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 2007 · Recalled
- 2 generations backK071379 Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc. · 2007
- 1 generation backK073676 Depuy Delta Xtend Reverse Shoulder High Mobility CupDePuy Orthopaedics, Inc. · 2008
- This deviceK081620 Modification to Depuy Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 2008
- Descendant · cites it directly · 108 of its ownK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- Descendant · 2 generations on · 97 of its ownK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- Descendant · 3 generations on · 96 of its ownK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- Descendant · 4 generations on · 29 of its ownK140082 Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S. · 2014
- Descendant · 4 generations on · 26 of its ownK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
Showing 5 of 109 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 109 · See all- K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · cites it directly108descendants
- K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 2 generations on97descendants
- K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · 3 generations on96descendants
- K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S. · 2014 · 4 generations on29descendants
- K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013 · 4 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −7 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −6 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −5 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −4 | K062116 | Delta Cta Reverse Shoulder System Humeral Heads | DePuy Orthopaedics, Inc. | 2006 | — |
| −3 | K062250 | Delta Xtend Reverse Shoulder System | DePuy Orthopaedics, Inc. | 2007 | 8 |
| −2 | K071379 | Delta Xtend Reverse Shoulder Modular Stem | DePuy Orthopaedics, Inc. | 2007 | — |
| −1 | K073676 | Depuy Delta Xtend Reverse Shoulder High Mobility Cup | DePuy Orthopaedics, Inc. | 2008 | — |
| 0 (this device) | K081620 | Modification to Depuy Delta Xtend Reverse Shoulder System | DePuy Orthopaedics, Inc. | 2008 | — |
| +1 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| +2 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| +3 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| +4 | K140082 | Aequalis (TM) Ascent (TM) Flex Shoulder System | Tornier S.A.S. | 2014 | — |
| +4 | K132285 | Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 8 | 0 |
| 2020 | 9 | 0 |
| 2021 | 10 | 0 |
| 2022 | 14 | 0 |
| 2023 | 10 | 0 |
| 2024 | 10 | 0 |
| 2025 | 12 | 0 |
| 2026 | 13 | 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 |
|---|---|---|---|
| * | K062250 | Delta Xtend Reverse Shoulder SystemSummary page 4…der Prosthesis ' Class Il per 21 CFR 888.3660: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented 87 KWS 87 HSD DePuy Delta Xtend Reverse Shoulder System, K062250 and K073676 The Delta Xtend Reverse Shoulder System is a modular shoulder prosthesis designed for use in patients with non-funct… | 2007 |
| * | K073676 | Depuy Delta Xtend Reverse Shoulder High Mobility CupSummary page 4…is ' Class Il per 21 CFR 888.3660: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented 87 KWS 87 HSD DePuy Delta Xtend Reverse Shoulder System, K062250 and K073676 The Delta Xtend Reverse Shoulder System is a modular shoulder prosthesis designed for use in patients with non-functional rotato… | 2008 |
What descends from it? (109)
See all 1091 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110599 | Aequalis Ascend Modular Reverse Shoulder System | 2011 | 108 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 10, 2008 | Not classified | Z-0536-2009 | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. |
| Jul 10, 2008 | Not classified | Z-0537-2009 | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. |
| Jul 10, 2008 | Not classified | Z-0539-2009 | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. |
| Jul 10, 2008 | Not classified | Z-0538-2009 | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. |
| Jul 10, 2008 | Not classified | Z-0532-2009 | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. |
| Jul 10, 2008 | Not classified | Z-0533-2009 | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. |
| Jul 10, 2008 | Not classified | Z-0534-2009 | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. |
| Jul 10, 2008 | Not classified | Z-0535-2009 | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 7 months on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K110599 (Tornier, Inc., 2011) has gone furthest, with 108 descendants of its own.
- 16 other devices also cite its predicate K062250.
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. 2008, 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 Delta Xtend Reverse Shoulder prosthesis is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous 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 to use the device. In cases of bone defects in the proximal humerus, the monobloc implant should…
Read the full statement (156 words)
The Delta Xtend Reverse Shoulder prosthesis is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous 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 to use the device.
In cases of bone defects in the proximal humerus, the monobloc implant should be used and then only in cases where the residual bone permits firm fixation of this implant.
Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for revision of a previously failed Delta Xtend Reverse Shoulder.
The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation.
The modular humeral stem and epiphysis components are HA coated and intended for cementless use.
All other components are for cemented use only.
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/K081620 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081620: Modification to Depuy Delta Xtend Reverse Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081620
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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