510(k) · Cleared
ClearedExactech® Equinoxe® Reverse Shoulder Glenospheres
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Feb 20, 2020 as substantially equivalent to K063569 (Exactech, Inc., 2007) and 3 other predicates after a 105-day review. Its family tree reaches back 11 generations to 1991.
- Decided
- Feb 20, 2020
- Review
- 105 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K911686 (1991). 43 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet.
- Root · 11 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 7 generations between
- 3 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 2 generations backK093275 Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and…Exactech, Inc. · 2010 · Recalled
- 1 generation backK110708 Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM…Exactech, Inc. · 2011
- This deviceK193098 Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc. · 2020
Show all 11 generations
- Root · 11 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 10 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 9 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 8 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 7 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 6 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 5 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 4 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 3 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 2 generations backK093275 Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and…Exactech, Inc. · 2010 · Recalled
- 1 generation backK110708 Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM…Exactech, Inc. · 2011
- This deviceK193098 Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −10 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −9 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −8 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −7 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −6 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −5 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −4 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −3 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −2 | K093275 | Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral Liner | Exactech, Inc. | 2010 | 3 |
| −1 | K110708 | Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere /… | Exactech, Inc. | 2011 | — |
| 0 (this device) | K193098 | Exactech® Equinoxe® Reverse Shoulder Glenospheres | Exactech, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2015 | 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.
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? (4)
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 |
|---|---|---|---|
| * | K063569 | Equinoxe Reverse Shoulder SystemSummary page 4…tantial Equivalence Is Claimed: Name Manufacturer 510(k) Number Equinoxe Reverse Shoulder System Exactech, Inc. K063569 Equinoxe Reverse Shoulder System 36mm Exactech, Inc. K093275 Glenosphere and… | 2007 |
| * | K093275 | Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerSummary page 4…xe Reverse Shoulder System Exactech, Inc. K063569 Equinoxe Reverse Shoulder System 36mm Exactech, Inc. K093275 Glenosphere and Humeral Liners Equinoxe Reverse Shoulder Line Extensions Exactech, Inc. K110708 Equinoxe Reverse Should… | 2010 |
| * | K110708 | Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Summary page 4…Exactech, Inc. K093275 Glenosphere and Humeral Liners Equinoxe Reverse Shoulder Line Extensions Exactech, Inc. K110708 Equinoxe Reverse Shoulder 46x21mm Exactech, Inc. K150458 Glenosphere Indicat… | 2011 |
| * | K150458 | Exactech Equinoxe Reverse Shoulder 46x21mm GlenosphereSummary page 4…uinoxe Reverse Shoulder Line Extensions Exactech, Inc. K110708 Equinoxe Reverse Shoulder 46x21mm Exactech, Inc. K150458 Glenosphere Indications for Use: The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals wit… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 14 of the 43 ancestors have a recall of any class.
- 15 other devices also cite its predicate K063569.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193098 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193098: Exactech® Equinoxe® Reverse Shoulder Glenospheres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193098
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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