510(k) · Cleared
ClearedEquinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior Augment Glenoid Plate, 10 Degrees...
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 Apr 1, 2011 as substantially equivalent to K063569 (Exactech, Inc., 2007) and 1 other predicate after an 18-day review. Its family tree reaches back 10 generations to 1991. 30 later devices descend from it.
- Decided
- Apr 1, 2011
- Review
- 18 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K911686 (1991). 41 ancestors in all, the oldest K790987 (1979). 30 later devices descend from it, 5 citing it directly.
- 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 backK093275 Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and…Exactech, Inc. · 2010 · Recalled
- This deviceK110708 Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM…Exactech, Inc. · 2011
- Descendant · cites it directly · 20 of its ownK172502 Comprehensive Augmented Glenoid Components, Comprehensive Standard…Biomet Manufacturing Corp · 2018 · Recalled
- Descendant · 2 generations on · 12 of its ownK191746 SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2019
- Descendant · 2 generations on · 11 of its ownK200171 SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2020
- Descendant · 3 generations on · 8 of its ownK210717 Bone Screws dia. 5,0 mmLima Corporate S.P.A. · 2021
- Descendant · 4 generations on · 7 of its ownK220792 SMR Reverse LinerLima Corporate S.P.A. · 2022
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 backK093275 Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and…Exactech, Inc. · 2010 · Recalled
- This deviceK110708 Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM…Exactech, Inc. · 2011
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp · 2018 · cites it directly20descendants
- K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2019 · 2 generations on12descendants
- K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2020 · 2 generations on11descendants
- K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A. · 2021 · 3 generations on8descendants
- K220792SMR Reverse LinerLima Corporate S.P.A. · 2022 · 4 generations on7descendants
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 | K093275 | Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral Liner | Exactech, Inc. | 2010 | 3 |
| 0 (this device) | K110708 | Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere /… | Exactech, Inc. | 2011 | — |
| +1 | K172502 | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate… | Biomet Manufacturing Corp | 2018 | 1 |
| +2 | K191746 | SMR TT Augmented Glenoid System | Lima Corporate S.P.A. | 2019 | — |
| +2 | K200171 | SMR TT Augmented Glenoid System | Lima Corporate S.P.A. | 2020 | — |
| +3 | K210717 | Bone Screws dia. 5,0 mm | Lima Corporate S.P.A. | 2021 | — |
| +4 | K220792 | SMR Reverse Liner | Lima Corporate S.P.A. | 2022 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 2 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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 5…hesis], Class II, Product Code KWS) Legally Marketed Devices to Which Substantial Equivalence Is Claimed 510(k) Number Trade or Proprietary or Model Name Manufacturer K063569 Exactech Equinoxe Reverse Shoulder Exactech, Inc K093275 Exactech Equinoxe Reverse Shoulder Exactech, Inc. Device Description Th… | 2007 |
| * | K093275 | Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerSummary page 5…ices to Which Substantial Equivalence Is Claimed 510(k) Number Trade or Proprietary or Model Name Manufacturer K063569 Exactech Equinoxe Reverse Shoulder Exactech, Inc K093275 Exactech Equinoxe Reverse Shoulder Exactech, Inc. Device Description The modifications proposed by this submission describe mino… | 2010 |
What descends from it? (30)
See all 305 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172502 | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate… | 2018 | 20 |
| K131575 | Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left &… | 2013 | 6 |
| K180632 | Exactech Equinoxe Small Reverse Shoulder System | 2018 | 5 |
| K193098 | Exactech® Equinoxe® Reverse Shoulder Glenospheres | 2020 | 0 |
| K162325 | Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder… | 2017 | 0 |
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 20 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 14 of the 41 ancestors have a recall of any class.
- Of its descendants, K172502 (Biomet Manufacturing Corp, 2018) has gone furthest, with 20 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. 2011, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K110708 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110708: Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior Augment Glenoid Plate, 10 Degrees....” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110708
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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