510(k) · Cleared
ClearedIntegra TITAN Reverse Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra LifeSciences Corporation · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Aug 25, 2016 as substantially equivalent to K130050 (Ascension Orthopedic, 2013) after a 120-day review. Its family tree reaches back 14 generations to 1991. 1 of the 114 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.
- Decided
- Aug 25, 2016
- Review
- 120 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K911686 (1991). 105 ancestors in all, the oldest K790987 (1979). 8 later devices descend from it, 4 citing it directly. 1 of the 114 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 10 generations between
- 3 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 2 generations backK120739 Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc. · 2012
- 1 generation backK130050 Titan Reverse Shoulder SystemAscension Orthopedic · 2013
- This deviceK161189 Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2016
- Descendant · cites it directly · 4 of its ownK190588 Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2019
- Descendant · cites it directly · 3 of its ownK173717 Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2018
- Descendant · 2 generations on · 2 of its ownK181999 Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2018
- Descendant · 2 generations on · 1 of its ownK242253 JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie · 2024
- Descendant · 3 generations on · 0 of its ownK252411 JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie · 2025
Show all 14 generations
- Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 13 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 12 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 11 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 10 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 9 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 8 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 7 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 6 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 5 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 4 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 3 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 2 generations backK120739 Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc. · 2012
- 1 generation backK130050 Titan Reverse Shoulder SystemAscension Orthopedic · 2013
- This deviceK161189 Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2016
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder3 generations back · 2008
Most influential descendants
Showing 5 of 8 · See all- K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2019 · cites it directly4descendants
- K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2018 · cites it directly3descendants
- K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2018 · 2 generations on2descendants
- K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie · 2024 · 2 generations on1descendant
- K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −13 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −12 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −11 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −10 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −9 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −8 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −7 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −6 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −5 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −4 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −3 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −2 | K120739 | Aequalis Adjustable Modular Reverse Shoulder System | Tornier, Inc. | 2012 | — |
| −1 | K130050 | Titan Reverse Shoulder System | Ascension Orthopedic | 2013 | — |
| 0 (this device) | K161189 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | 2016 | — |
| +1 | K190588 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | 2019 | — |
| +1 | K173717 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | 2018 | — |
| +2 | K181999 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | 2018 | — |
| +2 | K242253 | JARVIS Glenoid Reverse Shoulder Prosthesis | FH Industrie | 2024 | — |
| +3 | K252411 | JARVIS Glenoid Reverse Shoulder Prosthesis | FH Industrie | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 5 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 6 | 0 |
| 2001 | 8 | 0 |
| 2002 | 1 | 0 |
| 2003 | 6 | 0 |
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 9 | 0 |
| 2007 | 6 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 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.
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 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? (1)
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 |
|---|---|---|---|
| * | K130050 | Titan Reverse Shoulder SystemSummary page 4…PHX 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed • Primary Predicate: Ascension® TITAN™ Reverse Shoulder System Glenoid (K130050) • Reference Device: Lima SMR Reverse Shoulder System (K110598) • Reference Device Tornier Aequalis Reversed Fracture (K112… | 2013 |
| † | K110598 | SMR Reverse Shoulder System | 2011 |
| † | K112144 | Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis… | 2012 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 9 companies; a new generation was cleared every 1.0 years on median.
- 29 of the 105 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K190588 (Integra LifeSciences Corporation, 2019) has gone furthest, with 4 descendants of its own.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
The Titan Reverse Shoulder System is indicated for use in 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 mmplants and a functional deltoid muscle i1s necessary to use the device. The Titan Reverse Shoulder System is indicated for primary. fractures-including proximal…
Read the full statement (124 words)
The Titan Reverse Shoulder System is indicated for use in 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 mmplants and a functional deltoid muscle i1s necessary to use the device. The Titan Reverse Shoulder System is indicated for primary. fractures-including proximal humeral. or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The glenoid base plate i1s intended for cementless application with the addition of screws for fixation. The humeral stem is indicated for cemented or uncemented use and the humeral body component is intended for cementless 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/K161189 · printed Nov 4, 2026
Cite this page
510(k) Report. “K161189: Integra TITAN Reverse Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K161189
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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