510(k) Report

510(k) · Cleared

Cleared

Depuy Delta Xtend Reverse Shoulder XLK Cup

K091751510(k) SpecialCleared Jul 14, 200928-day reviewClass II21 CFR 888.3660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

DePuy Orthopaedics, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Cleared on Jul 14, 2009 as substantially equivalent to K073676 (DePuy Orthopaedics, Inc., 2008) and 1 other predicate after a 28-day review. Its family tree reaches back 8 generations to 1991. 159 later devices descend from it.

Decided
Jul 14, 2009
Review
28 days
Class
Class II
Product code
KWS
Recalls
None
Predicates
2

Its longest line of descent runs back 8 generations to K911686 (1991). 15 ancestors in all, the oldest K800494 (1980). 159 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1999: 2 other ancestors1998: 1 other ancestor1992: 1 other ancestor1980: 2 other ancestors2014: 9 descendants cleared2011: 5 descendants cleared2010: 1 descendant cleared2015: 4 descendants cleared2013: 6 descendants cleared2017: 9 descendants cleared2012: 2 descendants cleared2022: 17 descendants cleared2021: 15 descendants cleared2019: 12 descendants cleared2025: 14 descendants cleared2018: 11 descendants cleared2016: 4 descendants cleared2023: 14 descendants cleared2020: 11 descendants cleared2024: 10 descendants cleared2026: 15 descendants clearedK911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991K984541 · Global FX Humeral Stem, Global Advantage Humeral Head · DePuy Orthopaedics, Inc. · 1999K992065 · Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head · DePuy Orthopaedics, Inc. · 1999K021478 · Delta Shoulder · Depuy, Inc. · 2003×2: 2 generations cleared close together, K062116 (2006), K062250 (2007) ×2: 2 generations cleared close together, K071379 (2007), K073676 (2008) 19801990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 4 other ancestors4 generations back: 3 other ancestors 1 generation forward: 5 descendants2 generations forward: 21 descendants3 generations forward: 35 descendants4 generations forward: 28 descendants5 generations forward: 26 descendants6 generations forward: 26 descendants7 generations forward: 16 descendants8 generations forward: 2 descendants K073676 · Depuy Delta Xtend Reverse Shoulder High Mobility Cup · DePuy Orthopaedics, Inc. · 2008K071379 · Delta Xtend Reverse Shoulder Modular Stem · DePuy Orthopaedics, Inc. · 2007K062250 · Delta Xtend Reverse Shoulder System · DePuy Orthopaedics, Inc. · 2007 · recalledK062116 · Delta Cta Reverse Shoulder System Humeral Heads · DePuy Orthopaedics, Inc. · 2006K021478 · Delta Shoulder · Depuy, Inc. · 2003K992065 · Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head · DePuy Orthopaedics, Inc. · 1999K984541 · Global FX Humeral Stem, Global Advantage Humeral Head · DePuy Orthopaedics, Inc. · 1999K911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991−50+5
  1. Root · 8 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 7 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 6 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 5 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 4 generations backK062116 Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006
  6. 3 generations backK062250 Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 2007 · Recalled
  7. 2 generations backK071379 Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc. · 2007
  8. 1 generation backK073676 Depuy Delta Xtend Reverse Shoulder High Mobility CupDePuy Orthopaedics, Inc. · 2008
  9. This deviceK091751 Depuy Delta Xtend Reverse Shoulder XLK CupDePuy Orthopaedics, Inc. · 2009
  10. Descendant · cites it directly · 147 of its ownK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
  11. Descendant · 2 generations on · 108 of its ownK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  12. Descendant · 3 generations on · 97 of its ownK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  13. Descendant · 4 generations on · 96 of its ownK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
  14. Descendant · cites it directly · 44 of its ownK110598 SMR Reverse Shoulder SystemLima Corporate S.P.A. · 2011 · Recalled

Showing 5 of 159 descendants. See all descendants

Descendants cleared per year

2010: 12011: 52012: 22013: 62014: 92015: 42016: 42017: 92018: 112019: 122020: 112021: 152022: 172023: 142024: 102025: 142026: 15
2010high 17 (2022) · low 1 (2010)2026

Most influential descendants

Showing 5 of 159 · See all
  • K100142Aequalis Reversed Shoulder ProsthesisTornier · 2010 · cites it directly147descendants
  • K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 2 generations on108descendants
  • K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 3 generations on97descendants
  • K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · 4 generations on96descendants
  • K110598SMR Reverse Shoulder SystemLima Corporate S.P.A. · 2011 · cites it directly44descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−7K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−6K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−5K021478Delta ShoulderDepuy, Inc.2003—
−4K062116Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc.2006—
−3K062250Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.20078
−2K071379Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc.2007—
−1K073676Depuy Delta Xtend Reverse Shoulder High Mobility CupDePuy Orthopaedics, Inc.2008—
0 (this device)K091751Depuy Delta Xtend Reverse Shoulder XLK CupDePuy Orthopaedics, Inc.2009—
+1K100142Aequalis Reversed Shoulder ProsthesisTornier2010—
+2K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
+3K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
+4K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.20132
+1K110598SMR Reverse Shoulder SystemLima Corporate S.P.A.20111

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198020
199210
199810
199920
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201150
201220
201360
201490
201540
201640
201790
2018110
2019120
2020110
2021150
2022170
2023140
2024100
2025140
2026150
FIG. 1 — Lineage of K091751, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K220847 AETOS Shoulder Systemscore 21.1 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K073676Depuy Delta Xtend Reverse Shoulder High Mobility Cup
Summary page 4
…i-constrained cemented prosthesis. 87 HSD: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. DePuy Delta Xtend Reverse Shoulder High Mobility Cup, K073676 DePuy Delta Xtend Reverse Shoulder System, K071379 DcPuy Orthopaedics, Inc. - - Delta Xtend Reverse Sheulder XLK Cup 40f78 ===…
DePuy Orthopaedics, Inc.2008—
*K071379Delta Xtend Reverse Shoulder Modular Stem
Summary page 4
…joint humeral (hemi-shoulder) metallic uncemented prosthesis. DePuy Delta Xtend Reverse Shoulder High Mobility Cup, K073676 DePuy Delta Xtend Reverse Shoulder System, K071379 DcPuy Orthopaedics, Inc. - - Delta Xtend Reverse Sheulder XLK Cup 40f78 DEVICE DESCRIPTION: The Delta Xtend Rev…
DePuy Orthopaedics, Inc.2007—

Also cleared against K073676: 2 other devices →

What descends from it? (159)

See all 159

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K100142Aequalis Reversed Shoulder ProsthesisTornier2010147
K110598SMR Reverse Shoulder SystemLima Corporate S.P.A.201144
K142139SMR 40MM GlenosphereLima Corporate S.P.A.201413
K103251Duocentric ReversedAston Medical20117
K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140

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 18 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
  • 2 of the 15 ancestors have a recall of any class.
  • Of its descendants, K100142 (Tornier, 2010) has gone furthest, with 147 descendants of its own.
  • 2 other devices also cite its predicate K073676.

How does its category compare?

All KWS devices

KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · KWS

3in 2025

2007: 22008: 42009: 42010: 72011: 112012: 72013: 122014: 72015: 82016: 102017: 72018: 42019: 92020: 32021: 52022: 52023: 42024: 22025: 32026 (partial year): 2
2007high 12 (2013) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWS

97in 2025

2008: 37 days median2009: 108 days median2010: 33 days median2011: 90 days median2012: 86 days median2013: 120 days median2014: 89 days median2015: 129 days median2016: 114 days median2017: 120 days median2018: 152 days median2019: 106 days median2020: 98 days median2021: 151 days median2022: 158 days median2023: 250 days median2025: 97 days median
2007high 250 (2023) · low 33 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWS

2in 2023

2007: 212008: 292010: 102011: 112012: 102014: 12016: 12017: 42018: 12019: 22020: 52023: 22026 (partial year): 1
2007high 29 (2008) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWS

2,281in 2025

2007: 1582008: 2382009: 2942010: 3932011: 4862012: 5422013: 8182014: 1,0662015: 1,1702016: 9702017: 1,6812018: 1,5452019: 1,7282020: 1,5672021: 1,3582022: 1,2682023: 1,7502024: 2,1222025: 2,281
2007high 2,281 (2025) · low 158 (2007)2025

MAUDE reports naming product code KWS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—21158
200843729238
200941080294
201073310393
2011119011486
201278610542
2013121200818
201478911,066
2015812901,170
2016101141970
2017712041,681
2018415211,545
2019910621,728
202039851,567
2021515101,358
2022515801,268
2023425021,750
20242—02,122
202539702,281
20262—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.

Also cleared against K073676

2 other devices cite the same predicate.

  • K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  • K081620Modification to Depuy Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 20088 recalls

More from DePuy Orthopaedics, Inc.

361 FDA decisions under this applicant name. See the company

  • P070026/S129Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S130CERAMAX Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S128CERAMAX® Ceramic Total Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S127Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc. · 2026

Recent decisions in KWS

The KWS category page

  • K260721Tornier Perform Advanced GlenoidTornier, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026
  • K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc. · 2025
  • K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc. · 2025
  • K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A. · 2025

https://510kreport.com/device/K091751 · printed Nov 6, 2026

Cite this page

510(k) Report. “K091751: Depuy Delta Xtend Reverse Shoulder XLK Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091751

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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