510(k) Report

510(k) · Cleared

Cleared

Delta Xtend Reverse Shoulder System

K183077510(k) TraditionalCleared May 17, 2019193-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 (Ireland) · PHX Shoulder Prosthesis, Reverse Configuration

Cleared on May 17, 2019 as substantially equivalent to K062250 (DePuy Orthopaedics, Inc., 2007) and 6 other predicates after a 193-day review. Its family tree reaches back 16 generations to 1991. 1 of the 140 devices in its family, counting itself, has a Class I recall.

Decided
May 17, 2019
Review
193 days
Class
Class II
Product code
PHX
Recalls
None
Predicates
7

Its longest line of descent runs back 16 generations to K911686 (1991). 139 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 140 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2014: 3 other ancestors2012: 6 other ancestors2008: 7 other ancestors2007: 5 other ancestors2006: 11 other ancestors2013: 2 other ancestors2011: 4 other ancestors2010: 3 other ancestors2009: 2 other ancestors2005: 7 other ancestors2004: 3 other ancestors2001: 7 other ancestors2000: 9 other ancestors1999: 5 other ancestors1995: 2 other ancestors2003: 6 other ancestors1998: 6 other ancestors1996: 7 other ancestors1980: 2 other ancestors1994: 6 other ancestors1992: 2 other ancestors1987: 5 other ancestors2002: 3 other ancestors1997: 2 other ancestors1993: 1 other ancestor1991: 3 other ancestors1989: 1 other ancestor1986: 1 other ancestor1979: 1 other ancestor1988: 1 other ancestorK911686 · 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, K030941 (2004), K041873 (2004) ×2: 2 generations cleared close together, K052906 (2005), K060704 (2006) K063569 · Equinoxe Reverse Shoulder System · Exactech, Inc. · 2007 · recalled×2: 2 generations cleared close together, K073688 (2008), K080642 (2008) ×2: 2 generations cleared close together, K110599 (2011), K112615 (2011) K122698 · Aequalis Ascend Flex Shoulder System · Tornier S.A.S. · 2013 · recalledK132285 · Aequalis Reversed Shoulder Prosthesis · Tornier S.A.S. · 2013K151293 · Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis · Tornier S.A.S. · 201519801990200020102020
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 17 other ancestors3 generations back: 23 other ancestors4 generations back: 25 other ancestors5 generations back: 16 other ancestors6 generations back: 23 other ancestors7 generations back: 9 other ancestors8 generations back: 2 other ancestors9 generations back: 2 other ancestors10 generations back: 1 other ancestor K151293 · Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis · Tornier S.A.S. · 2015K132285 · Aequalis Reversed Shoulder Prosthesis · Tornier S.A.S. · 2013K122698 · Aequalis Ascend Flex Shoulder System · Tornier S.A.S. · 2013 · recalledK112615 · Aequalis Ascend Modular Reverse Shoulder System · Tornier, Inc. · 2011K110599 · Aequalis Ascend Modular Reverse Shoulder System · Tornier, Inc. · 2011K080642 · Comprehensive Reverse Shoulder · Biomet, Inc. · 2008 · Class I recallK073688 · Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw · Exactech, Inc. · 2008 · recalledK063569 · Equinoxe Reverse Shoulder System · Exactech, Inc. · 2007 · recalledK060704 · Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM · Zimmer, Inc. · 2006 · recalledK052906 · Zimmer Trabecular Metal Reverse Shoulder System · Zimmer, Inc. · 2005 · recalledK041873 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2004K030941 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2004K021478 · 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. · 1991−15−10−50
  1. Root · 16 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 12 generations between
  3. 3 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
  4. 2 generations backK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
  5. 1 generation backK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
  6. This deviceK183077 Delta Xtend Reverse Shoulder SystemDepuy (Ireland) · 2019
Show all 16 generations
  1. Root · 16 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 15 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 14 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 13 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 12 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. 11 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. 10 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
  8. 9 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
  9. 8 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
  10. 7 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
  11. 6 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
  12. 5 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  13. 4 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  14. 3 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
  15. 2 generations backK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
  16. 1 generation backK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
  17. This deviceK183077 Delta Xtend Reverse Shoulder SystemDepuy (Ireland) · 2019

Class I recalls in this family

  • K080642 Comprehensive Reverse Shoulder2 generations back · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−16K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−15K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−14K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−13K021478Delta ShoulderDepuy, Inc.2003—
−12K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
−11K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
−10K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200512
−9K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200610
−8K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200713
−7K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081
−6K080642Comprehensive Reverse ShoulderBiomet, Inc.2008Class I
−5K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
−4K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
−3K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.20132
−2K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.2013—
−1K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.2015—
0 (this device)K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198020
198610
198750
198810
198910
199130
199220
199310
199460
199520
199670
199720
199860
199950
200090
200170
200230
200360
200430
200570
2006110
200750
200870
200920
201030
201140
201260
201320
201430
FIG. 1 — Lineage of K183077, 1991–2019Source: 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.

1 device in this family has a Class I recall. 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 PHX device

  1. #1 K212737 INHANCE™ Reverse Shoulder Systemscore 28.4 · 15 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? (7)

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
*K062250Delta Xtend Reverse Shoulder System
Summary page 4
…PHX, KWS, HSD Classification panel Orthopedics panel Legally marketed DELTA XTEND Reverse Shoulder System (DePuy: K062250, device(s) to which K120174), equivalence is claimed Aequalis Reversed Prosthesis (Tornier SAS: K03…
DePuy Orthopaedics, Inc.20078
*K120174Deput Delta Xtend Reverse Shoulder
Summary page 4
…ation panel Orthopedics panel Legally marketed DELTA XTEND Reverse Shoulder System (DePuy: K062250, device(s) to which K120174), equivalence is claimed Aequalis Reversed Prosthesis (Tornier SAS: K030941, K061439,…
Depuy France20122
*K030941Aequalis Reversed Shoulder Prosthesis
Summary page 4
…END Reverse Shoulder System (DePuy: K062250, device(s) to which K120174), equivalence is claimed Aequalis Reversed Prosthesis (Tornier SAS: K030941, K061439, K081059, K140478, K151293) Reason for 510(k) Addition of laterali…
Tornier2004—
*K061439Aequalis Reversed Prosthesis
Summary page 4
…se Shoulder System (DePuy: K062250, device(s) to which K120174), equivalence is claimed Aequalis Reversed Prosthesis (Tornier SAS: K030941, K061439, K081059, K140478, K151293) Reason for 510(k) Addition of lateralized gleno…
Tornier2006—
*K081059Aequalis Reversed Shoulder Prosthesis
Summary page 4
…to which K120174), equivalence is claimed Aequalis Reversed Prosthesis (Tornier SAS: K030941, K061439, K081059, K140478, K151293) Reason for 510(k) Addition of lateralized glenosphere components to the Delta Xtend submissi…
Tornier2008—
*K140478Aequalis Reversed Shoulder Prosthesis
Summary page 4
…K120174), equivalence is claimed Aequalis Reversed Prosthesis (Tornier SAS: K030941, K061439, K081059, K140478, K151293) Reason for 510(k) Addition of lateralized glenosphere components to the Delta Xtend submission…
Tornier S.A.S.2014—
*K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis
Summary page 4
…K120174), equivalence is claimed Aequalis Reversed Prosthesis (Tornier SAS: K030941, K061439, K081059, K140478, K151293) Reason for 510(k) Addition of lateralized glenosphere components to the Delta Xtend submission…
Tornier S.A.S.2015—

Also cleared against K062250: 16 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 28 years and passes through 9 companies; a new generation was cleared every 1.0 years on median.
  • 34 of the 139 ancestors have a recall of any class; 1 has a Class I recall.
  • 16 other devices also cite its predicate K062250.

How does its category compare?

All PHX devices

PHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · PHX

9in 2025

2007: 52008: 62009: 12010: 82011: 122012: 122013: 82014: 122015: 42016: 42017: 112018: 142019: 92020: 132021: 212022: 92023: 92024: 92025: 92026 (partial year): 18
2007high 21 (2021) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PHX

72in 2025

2007: 97 days median2008: 79 days median2010: 124 days median2011: 94 days median2012: 114 days median2013: 143 days median2014: 110 days median2015: 206 days median2016: 132 days median2017: 141 days median2018: 127 days median2019: 144 days median2020: 143 days median2021: 143 days median2022: 198 days median2023: 154 days median2024: 139 days median2025: 72 days median2026 (partial year): 130 days median
2007high 206 (2015) · low 72 (2025)2026

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

Recalls per year · PHX

3in 2025

2015: 22018: 12019: 32020: 32021: 82023: 72024: 12025: 32026 (partial year): 7
2007high 8 (2021) · low 0 (2007)2026

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

Adverse event reports per year · PHX

2,848in 2025

2015: 142016: 52017: 252018: 3232019: 5042020: 9862021: 1,4042022: 1,3422023: 1,4012024: 2,1422025: 2,848
2007high 2,848 (2025) · low 0 (2007)2025

MAUDE reports naming product code PHX, 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
200759700
200867900
20091—00
2010812400
2011129400
20121211400
2013814300
20141211000
20154206214
2016413205
201711141025
2018141271323
201991443504
2020131433986
20212114381,404
2022919801,342
2023915471,401
2024913912,142
202597232,848
2026181307—

What is it indicated for?

The Delta Xtend Shoulder Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with: • severe arthropathy and/or; • a previously failed joint replacement and/or: • 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 The patient's joint must be…

Read the full statement (158 words)

The Delta Xtend Shoulder Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with:

• severe arthropathy and/or;

• a previously failed joint replacement and/or:

• 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

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.

Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the 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 humeral epiphysis components are HA coated and intended for cementless use.

All other metallic components are intended for cemented use only.

Indications for use as stated in the FDA summary.

Also cleared against K062250

16 other devices cite the same predicate.

  • K250338MSS - Humeral reverse liners extensionMedacta International S.A. · 2025
  • K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 2021
  • K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland) · 2019
  • K170452Medacta Shoulder SystemMedacta International S.A. · 2017
  • K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp. · 2013
  • K130050Titan Reverse Shoulder SystemAscension Orthopedic · 2013

More from Depuy (Ireland)

13 FDA decisions under this applicant name. See the company

  • K212683GLOBAL ICON Stemless Shoulder SystemDepuy (Ireland) · 2022
  • K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland) · 2020
  • K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland) · 2019
  • K191779Attune Revision LPS InsertsDepuy (Ireland) · 20194 recalls
  • K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland) · 2019

Recent decisions in PHX

The PHX category page

  • K263421Veritas Shoulder Systemrestor3d, inc. · 2026
  • K263086AltiVate Reverse® Glenosphere with RAVN™ TechnologyEncore Medical L.P. · 2026
  • K260556Veritas Shoulder SystemRestor3D · 2026
  • K261683Augment Off-Axis Instrument SystemZimmer, Inc. · 2026
  • K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.) · 2026

https://510kreport.com/device/K183077 · printed Nov 5, 2026

Cite this page

510(k) Report. “K183077: 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/K183077

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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