510(k) · Cleared
ClearedJARVIS Glenoid Reverse Shoulder Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
FH Industrie · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Aug 28, 2025 as substantially equivalent to K242253 (FH Industrie, 2024) after a 27-day review. Its family tree reaches back 17 generations to 1991. 1 of the 173 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 28, 2025
- Review
- 27 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K911686 (1991). 172 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 173 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 13 generations between
- 3 generations backK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
- 2 generations backK171789 ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie · 2018
- 1 generation backK242253 JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie · 2024
- This deviceK252411 JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie · 2025
Show all 17 generations
- Root · 17 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 16 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 15 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 14 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 13 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 12 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 11 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 10 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 9 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 8 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 7 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 6 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 5 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 4 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 3 generations backK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
- 2 generations backK171789 ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie · 2018
- 1 generation backK242253 JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie · 2024
- This deviceK252411 JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie · 2025
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder3 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −16 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −15 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −14 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −13 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −12 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −11 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −10 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −9 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −8 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −7 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −6 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −5 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −4 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| −3 | K132285 | Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2013 | — |
| −2 | K171789 | ARROW Reverse Porous Glenoid | Fournitures Hospitalieres Industrie | 2018 | — |
| −1 | K242253 | JARVIS Glenoid Reverse Shoulder Prosthesis | FH Industrie | 2024 | — |
| 0 (this device) | 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 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 4 | 0 |
| 1996 | 9 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 12 | 0 |
| 2001 | 9 | 0 |
| 2002 | 3 | 0 |
| 2003 | 6 | 0 |
| 2004 | 7 | 0 |
| 2005 | 8 | 0 |
| 2006 | 13 | 0 |
| 2007 | 6 | 0 |
| 2008 | 7 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 7 | 0 |
| 2012 | 8 | 0 |
| 2013 | 5 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K242253 | JARVIS Glenoid Reverse Shoulder ProsthesisSummary page 5…Panel: Orthopedic Product Code: PHX Primary Predicate: FH Industrie: JARVIS Glenoid Reverse Shoulder Prosthesis – K242253 Device Description: The JARVIS Glenoid Reverse Shoulder Prosthesis is used for reverse shoulder prosthesis, intendedfor primar… | 2024 |
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 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 10 companies; a new generation was cleared every 11 months on median.
- 47 of the 172 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
REVERSE PROSTHESIS
The Jarvis Glenoid Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff.
The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The glenoid baseplate is intended for cementless application with the addition of screws for fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252411 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252411: JARVIS Glenoid Reverse Shoulder Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252411
Report an extraction error
Are you the manufacturer?
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