510(k) · Cleared
Recalled · Class II · 2024Exactech Equinoxe Small Reverse Shoulder System
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 Jul 25, 2018 as substantially equivalent to K063569 (Exactech, Inc., 2007) and 4 other predicates after a 135-day review. Its family tree reaches back 12 generations to 1991. 5 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 25, 2018
- Review
- 135 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 3
- Predicates
- 5
Its longest line of descent runs back 12 generations to K911686 (1991). 61 ancestors in all, the oldest K790987 (1979). 5 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 8 generations between
- 3 generations backK093275 Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and…Exactech, Inc. · 2010 · Recalled
- 2 generations backK110708 Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM…Exactech, Inc. · 2011
- 1 generation backK131575 Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid…Exactech, Inc. · 2013
- This deviceK180632 Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc. · 2018
- Descendant · cites it directly · 4 of its ownK182536 Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech…Exactech, Inc. · 2018 · Recalled
- Descendant · cites it directly · 2 of its ownK223833 Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc. · 2023 · Recalled
- Descendant · 2 generations on · 0 of its ownK260583 Equinoxe® Shoulder SystemExactech, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK243448 Equinoxe® Shoulder SystemExactech, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK233482 Equinoxe® Central Screw Baseplate SystemExactech, Inc. · 2024
Show all 12 generations
- Root · 12 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 11 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 10 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 9 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 8 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 7 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 6 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 5 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 4 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 3 generations backK093275 Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and…Exactech, Inc. · 2010 · Recalled
- 2 generations backK110708 Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM…Exactech, Inc. · 2011
- 1 generation backK131575 Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid…Exactech, Inc. · 2013
- This deviceK180632 Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc. · 2018
Most influential descendants
Showing 5 of 5 · See all- K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc. · 2018 · cites it directly4descendants
- K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc. · 2023 · cites it directly2descendants
- K260583Equinoxe® Shoulder SystemExactech, Inc. · 2026 · 2 generations on0descendants
- K243448Equinoxe® Shoulder SystemExactech, Inc. · 2025 · 2 generations on0descendants
- K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −11 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −10 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −9 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −8 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −7 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −6 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −5 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −4 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −3 | K093275 | Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral Liner | Exactech, Inc. | 2010 | 3 |
| −2 | K110708 | Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere /… | Exactech, Inc. | 2011 | — |
| −1 | K131575 | Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate… | Exactech, Inc. | 2013 | — |
| 0 (this device) | K180632 | Exactech Equinoxe Small Reverse Shoulder System | Exactech, Inc. | 2018 | — |
| +1 | K182536 | Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe… | Exactech, Inc. | 2018 | 3 |
| +1 | K223833 | Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays | Exactech, Inc. | 2023 | 1 |
| +2 | K260583 | Equinoxe® Shoulder System | Exactech, Inc. | 2026 | — |
| +2 | K243448 | Equinoxe® Shoulder System | Exactech, Inc. | 2025 | — |
| +2 | K233482 | Equinoxe® Central Screw Baseplate System | Exactech, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 6 | 0 |
| 2001 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (5)
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…tial Equivalence Is Claimed: Name Manufacturer 510(k) Number Equinoxe Reverse Shoulder System Exactech, Inc. K063569 Equinoxe Reverse Shoulder Line Extensions Exactech, Inc. K110708 Equinoxe Reverse Shoulder System 36mm… | 2007 |
| * | K110708 | Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Summary page 4…Manufacturer 510(k) Number Equinoxe Reverse Shoulder System Exactech, Inc. K063569 Equinoxe Reverse Shoulder Line Extensions Exactech, Inc. K110708 Equinoxe Reverse Shoulder System 36mm Exactech, Inc. K093275 Glenosphere and… | 2011 |
| * | K093275 | Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerSummary page 4…xe Reverse Shoulder Line Extensions Exactech, Inc. K110708 Equinoxe Reverse Shoulder System 36mm Exactech, Inc. K093275 Glenosphere and Humeral Liners Equinoxe Total Shoulder – Fixed Angle Replicator Plates, Cast Humeral Heads, and Cast Exactech,… | 2010 |
| * | K102951 | Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Summary page 4…Exactech, Inc. K093275 Glenosphere and Humeral Liners Equinoxe Total Shoulder – Fixed Angle Replicator Plates, Cast Humeral Heads, and Cast Exactech, Inc. K102951 Glenosphere Equinoxe Superior/Posterior Augment Reverse Exactech, Inc. K13157… | 2010 |
| * | K131575 | Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left &…Summary page 4…umeral Heads, and Cast Exactech, Inc. K102951 Glenosphere Equinoxe Superior/Posterior Augment Reverse Exactech, Inc. K131575 Shoulder Glenoid Baseplate Indications for Use: The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature… | 2013 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 6, 2024 | Class II | Z-1420-2024 | Nonconforming Material/Component | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer… |
| Mar 6, 2024 | Class II | Z-1421-2024 | Nonconforming Material/Component | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer… |
| Nov 21, 2023 | Class II | Z-0579-2024 | Packaging change control | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 17 of the 61 ancestors have a recall of any class.
- Of its descendants, K182536 (Exactech, Inc., 2018) has gone furthest, with 4 descendants of its own.
- 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. 2018, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180632 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180632: Exactech Equinoxe Small 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/K180632
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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