510(k) · Cleared
ClearedDelta Xtend Reverse Shoulder Modular Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Sep 11, 2007 as substantially equivalent to K062250 (DePuy Orthopaedics, Inc., 2007) and 2 other predicates after a 117-day review. Its family tree reaches back 6 generations to 1991. 191 later devices descend from it.
- Decided
- Sep 11, 2007
- Review
- 117 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K911686 (1991). 13 ancestors in all, the oldest K800494 (1980). 191 later devices descend from it, 10 citing it directly.
- Root · 6 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 5 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 4 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 3 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 2 generations backK062116 Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006
- 1 generation backK062250 Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 2007 · Recalled
- This deviceK071379 Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc. · 2007
- Descendant · cites it directly · 164 of its ownK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- Descendant · cites it directly · 161 of its ownK073676 Depuy Delta Xtend Reverse Shoulder High Mobility CupDePuy Orthopaedics, Inc. · 2008
- Descendant · cites it directly · 159 of its ownK091751 Depuy Delta Xtend Reverse Shoulder XLK CupDePuy Orthopaedics, Inc. · 2009
- Descendant · cites it directly · 147 of its ownK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
- Descendant · 2 generations on · 109 of its ownK081620 Modification to Depuy Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 2008 · Recalled
Showing 5 of 191 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 191 · See all- K082120Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008 · cites it directly164descendants
- K073676Depuy Delta Xtend Reverse Shoulder High Mobility CupDePuy Orthopaedics, Inc. · 2008 · cites it directly161descendants
- K091751Depuy Delta Xtend Reverse Shoulder XLK CupDePuy Orthopaedics, Inc. · 2009 · cites it directly159descendants
- K100142Aequalis Reversed Shoulder ProsthesisTornier · 2010 · cites it directly147descendants
- K081620Modification to Depuy Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 2008 · 2 generations on109descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −5 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −4 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −3 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −2 | K062116 | Delta Cta Reverse Shoulder System Humeral Heads | DePuy Orthopaedics, Inc. | 2006 | — |
| −1 | K062250 | Delta Xtend Reverse Shoulder System | DePuy Orthopaedics, Inc. | 2007 | 8 |
| 0 (this device) | K071379 | Delta Xtend Reverse Shoulder Modular Stem | DePuy Orthopaedics, Inc. | 2007 | — |
| +1 | K082120 | Aequalis Reversed Fracture Shoulder Prothesis | Tornier | 2008 | — |
| +1 | K073676 | Depuy Delta Xtend Reverse Shoulder High Mobility Cup | DePuy Orthopaedics, Inc. | 2008 | — |
| +1 | K091751 | Depuy Delta Xtend Reverse Shoulder XLK Cup | DePuy Orthopaedics, Inc. | 2009 | — |
| +1 | K100142 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2010 | — |
| +2 | K081620 | Modification to Depuy Delta Xtend Reverse Shoulder System | DePuy Orthopaedics, Inc. | 2008 | 8 |
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 |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 6 | 0 |
| 2014 | 11 | 0 |
| 2015 | 4 | 0 |
| 2016 | 6 | 0 |
| 2017 | 12 | 0 |
| 2018 | 13 | 0 |
| 2019 | 14 | 0 |
| 2020 | 16 | 0 |
| 2021 | 21 | 0 |
| 2022 | 18 | 0 |
| 2023 | 15 | 0 |
| 2024 | 10 | 0 |
| 2025 | 14 | 0 |
| 2026 | 15 | 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 PHX? 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 K212737 INHANCE™ Reverse Shoulder Systemscore 28.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 1…T Reverse Shoulder System, DEVICE: K062250 DePuy Delta CTA Reverse Shoulder System,… | 2007 |
| * | K021478 | Delta ShoulderSummary page 1…K062250 DePuy Delta CTA Reverse Shoulder System, K021478 DePuy Global Advantage Shoulder System,… | 2003 |
| * | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric HeadSummary page 1…K021478 DePuy Global Advantage Shoulder System, K992065 - 13 - DEVIC… | 1999 |
What descends from it? (191)
See all 19110 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082120 | Aequalis Reversed Fracture Shoulder Prothesis | 2008 | 164 |
| K073676 | Depuy Delta Xtend Reverse Shoulder High Mobility Cup | 2008 | 161 |
| K091751 | Depuy Delta Xtend Reverse Shoulder XLK Cup | 2009 | 159 |
| K100142 | Aequalis Reversed Shoulder Prosthesis | 2010 | 147 |
| K112144 | Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis… | 2012 | 23 |
| K101996 | Depuy Global Unite Shoulder System | 2010 | 16 |
| K170452 | Medacta Shoulder System | 2017 | 12 |
| K192855 | DELTA XTEND (TM) Reverse Shoulder System | 2020 | 3 |
| K192448 | Delta Xtend Revers Shoulder System | 2019 | 1 |
| K210167 | DELTA XTEND Reverse Shoulder System | 2021 | 0 |
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 16 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K082120 (Tornier, 2008) has gone furthest, with 164 descendants of its own.
- 16 other devices also cite its predicate K062250.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · PHX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PHX
72in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PHX
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PHX
2,848in 2025
MAUDE reports naming product code PHX, 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 | 5 | 97 | 0 | 0 |
| 2008 | 6 | 79 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 8 | 124 | 0 | 0 |
| 2011 | 12 | 94 | 0 | 0 |
| 2012 | 12 | 114 | 0 | 0 |
| 2013 | 8 | 143 | 0 | 0 |
| 2014 | 12 | 110 | 0 | 0 |
| 2015 | 4 | 206 | 2 | 14 |
| 2016 | 4 | 132 | 0 | 5 |
| 2017 | 11 | 141 | 0 | 25 |
| 2018 | 14 | 127 | 1 | 323 |
| 2019 | 9 | 144 | 3 | 504 |
| 2020 | 13 | 143 | 3 | 986 |
| 2021 | 21 | 143 | 8 | 1,404 |
| 2022 | 9 | 198 | 0 | 1,342 |
| 2023 | 9 | 154 | 7 | 1,401 |
| 2024 | 9 | 139 | 1 | 2,142 |
| 2025 | 9 | 72 | 3 | 2,848 |
| 2026 | 18 | 130 | 7 | — |
What is it indicated for?
Delta XtendTM Reverse Shoulder prosthesis is indicated for use in a grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient 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…
Read the full statement (154 words)
Delta XtendTM Reverse Shoulder prosthesis is indicated for use in a grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient 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 finn fixation of this implant.
Delta XtendTM 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 stein and epiphysis components are HA coated and intended for cementless use.
All other components are for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071379 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071379: Delta Xtend Reverse Shoulder Modular Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071379
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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