510(k) · Cleared
Recalled · Class II · 2021Exactech Equinoxe Humeral Augmented Trays
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 Aug 20, 2019 as substantially equivalent to K063569 (Exactech, Inc., 2007) and 1 other predicate after a 68-day review. Its family tree reaches back 10 generations to 1991. It has been recalled once.
- Decided
- Aug 20, 2019
- Review
- 68 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 10 generations to K911686 (1991). 41 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet.
- Root · 10 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 6 generations between
- 3 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 2 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 1 generation backK082702 Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter TrayExactech, Inc. · 2008
- This deviceK191561 Exactech Equinoxe Humeral Augmented TraysExactech, Inc. · 2019
Show all 10 generations
- Root · 10 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 9 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 8 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 7 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 6 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 5 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 4 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 3 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 2 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 1 generation backK082702 Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter TrayExactech, Inc. · 2008
- This deviceK191561 Exactech Equinoxe Humeral Augmented TraysExactech, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −9 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −8 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −7 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −6 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −5 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −4 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −3 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −2 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −1 | K082702 | Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter Tray | Exactech, Inc. | 2008 | — |
| 0 (this device) | K191561 | Exactech Equinoxe Humeral Augmented Trays | Exactech, Inc. | 2019 | — |
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 |
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? (2)
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…nel: Orthopedic Information on devices to which substantial equivalence is claimed: 510(k) Number Trade or Proprietary Model Name Manufacturer K063569 Equinoxe Reverse Shoulder System (Humeral Exactech, Inc Adapter Trays) K082702 Equinoxe R… | 2007 |
| * | K082702 | Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter TraySummary page 4…or Proprietary Model Name Manufacturer K063569 Equinoxe Reverse Shoulder System (Humeral Exactech, Inc Adapter Trays) K082702 Equinoxe Reverse Shoulder System + 15mm Exactech, Inc Humeral Adapter Tray… | 2008 |
| † | K143659 | Equinoxe Mega Prosthesis | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 11, 2021 | Class II | Z-1977-2021 | Device Design | The HAT trial contains a retaining ring that has shown the potential to disengage during use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 13 of the 41 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. 2019, 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 Humeral Augmented Tray is indicated for proximal humeral replacement in conjunction with reverse shoulder arthroplasty in skeletally mature individuals with an intact medial calcar for whom the rotator cuff is irreparable or grossly deficient, a functional deltoid muscle is present, and proximal humeral bone loss is present in cases of: • Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems • Congenital…
Read the full statement (186 words)
The Equinoxe Humeral Augmented Tray is indicated for proximal humeral replacement in conjunction with reverse shoulder arthroplasty in skeletally mature individuals with an intact medial calcar for whom the rotator cuff is irreparable or grossly deficient, a functional deltoid muscle is present, and proximal humeral bone loss is present in cases of:
• Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems
• Congenital abnormalities in the skeletally mature
• Primary and secondary necrosis of the humeral head
• Humeral head fracture with displacement of the tuberosities
• Pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable
• Revisions of humeral prostheses when other treatments or devices have failed (where adequate humeral stem fixation can be achieved)
• Displaced three- and four-part upper humeral fractures
• Failed ORIF requiring rTSA with an absent or deficient greater tuberosity
• Revision of failed previous reconstructions when distal anchorage is required
• Treatment of unplanned proximal bone loss during a revision
• To restore mobility from previous procedures (e.g. previous fusion)
The Equinoxe Humeral Augmented Tray can be used in either primary or revision arthroplasty procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191561 · printed Nov 4, 2026
Cite this page
510(k) Report. “K191561: Exactech Equinoxe Humeral Augmented Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K191561
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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