510(k) · Cleared
ClearedEquinoxe® 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 Aug 1, 2025 as substantially equivalent to K223833 (Exactech, Inc., 2023) after a 267-day review. Its family tree reaches back 18 generations to 1991. 1 of the 139 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 1, 2025
- Review
- 267 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K911686 (1991). 138 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 139 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 14 generations between
- 3 generations backK192206 32mm Glenosphere and Humeral CupFx Shoulder USA, Inc. · 2019 · Recalled
- 2 generations backK193394 Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc. · 2020
- 1 generation backK223833 Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc. · 2023 · Recalled
- This deviceK243448 Equinoxe® Shoulder SystemExactech, Inc. · 2025
Show all 18 generations
- Root · 18 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 17 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 16 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 15 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 14 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 13 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 12 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 11 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 10 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 9 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 8 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 7 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 6 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 5 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 4 generations backK163669 Humeris ShoulderFx Solutions · 2017
- 3 generations backK192206 32mm Glenosphere and Humeral CupFx Shoulder USA, Inc. · 2019 · Recalled
- 2 generations backK193394 Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc. · 2020
- 1 generation backK223833 Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc. · 2023 · Recalled
- This deviceK243448 Equinoxe® Shoulder SystemExactech, Inc. · 2025
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder7 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −17 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −16 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −15 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −14 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −13 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −12 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −11 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −10 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −9 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −8 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −7 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −6 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −5 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| −4 | K163669 | Humeris Shoulder | Fx Solutions | 2017 | — |
| −3 | K192206 | 32mm Glenosphere and Humeral Cup | Fx Shoulder USA, Inc. | 2019 | 1 |
| −2 | K193394 | Humeral Cup Stability & Humeral Cup 135/145o Stability | Fx Shoulder USA, Inc. | 2020 | — |
| −1 | K223833 | Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays | Exactech, Inc. | 2023 | 1 |
| 0 (this device) | K243448 | Equinoxe® Shoulder System | Exactech, Inc. | 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 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 8 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 9 | 0 |
| 2001 | 9 | 0 |
| 2002 | 1 | 0 |
| 2003 | 6 | 0 |
| 2004 | 7 | 0 |
| 2005 | 7 | 0 |
| 2006 | 10 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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.
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.
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 · 7 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 1.2 years on median.
- 41 of the 138 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K223833.
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?
The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi-arthroplasty is determined by the surgeon to be the preferred method of treatment. The cemented primary humeral stem, long/revision stem, fracture stems, and all Equinoxe glenoids are intended for cemented fixation. The press-fit humeral stems are intended for press-fit applications but…
Read the full statement (390 words)
The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi-arthroplasty is determined by the surgeon to be the preferred method of treatment.
The cemented primary humeral stem, long/revision stem, fracture stems, and all Equinoxe glenoids are intended for cemented fixation.
The press-fit humeral stems are intended for press-fit applications but may be used with bone cement at the discretion the surgeon.
The reverse humeral components are intended to be used in cemented applications or in revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon.
Humeral Heads are intended for use in cemented and press-fit applications.
Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows:
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 fixation can be achieved)
Displaced three-part and four-part upper humeral fractures
Spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases)
Revision of failed previous reconstructions when distal anchorage is required
To restore mobility from previous procedures (e.g. previous fusion)
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.
The Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures of the proximal humerus (hemi-arthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243448: Equinoxe® Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243448
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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