510(k) · Cleared
Recalled · Class II · 2020Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture Stem
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 Jan 7, 2010 as substantially equivalent to K042021 (Exactech, Inc., 2004) and 6 other predicates after a 108-day review. Its family tree reaches back 11 generations to 1991. 1 of the 82 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 7, 2010
- Review
- 108 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 2
- Predicates
- 7
Its longest line of descent runs back 11 generations to K911686 (1991). 79 ancestors in all, the oldest K790987 (1979). 2 later devices descend from it, 2 citing it directly. 1 of the 82 devices in this family, counting this one, has a Class I recall.
- 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 backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 1 generation backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- This deviceK092900 Exactech Equinoxe Platform Fracture Stem and Revision Platform…Exactech, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK131277 Seviin Fracture ShoulderIngen Orthopedics, LLC · 2013
- Descendant · cites it directly · 0 of its ownK101909 Exactech Equinoxe, Platform Fracture StemExactech, Inc. · 2010 · Recalled
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 backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 1 generation backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- This deviceK092900 Exactech Equinoxe Platform Fracture Stem and Revision Platform…Exactech, Inc. · 2010
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulderdirect predicate · 2008
Most influential descendants
Showing 2 of 2 · See allView 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 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −1 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| 0 (this device) | K092900 | Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture Stem | Exactech, Inc. | 2010 | — |
| +1 | K131277 | Seviin Fracture Shoulder | Ingen Orthopedics, LLC | 2013 | — |
| +1 | K101909 | Exactech Equinoxe, Platform Fracture Stem | Exactech, Inc. | 2010 | 4 |
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 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 6 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 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.
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? (7)
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 |
|---|---|---|---|
| * | K042021 | Exactech Equinoxe Shoulder SystemSummary page 5…ined, metal/polymer cemented (21 CFR 888.3660, Class I, Product Code KWS) Legally Marketed Devices to Which Substantial Equivalence Is Claimed Equinoxe Fracture Stem (#K042021) Equinoxe Fracture Humeral Adapter Tray (#K073688) Zimmer Anatomical Shoulder Fracture System (#¥K062029) Biomet Comprehensive… | 2004 |
| * | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewSummary page 5…s I, Product Code KWS) Legally Marketed Devices to Which Substantial Equivalence Is Claimed Equinoxe Fracture Stem (#K042021) Equinoxe Fracture Humeral Adapter Tray (#K073688) Zimmer Anatomical Shoulder Fracture System (#¥K062029) Biomet Comprehensive Shoulder Fracture System (#K023063) Biomet Compre… | 2008 |
| * | K062029 | Anatomical Shoulder Fracture SystemSummary page 5…h Substantial Equivalence Is Claimed Equinoxe Fracture Stem (#K042021) Equinoxe Fracture Humeral Adapter Tray (#K073688) Zimmer Anatomical Shoulder Fracture System (#¥K062029) Biomet Comprehensive Shoulder Fracture System (#K023063) Biomet Comprehensive Reverse Shoulder (#K080642) Tornier Aequalis Sh… | 2006 |
| * | K023063 | Comprehensive Humeral Fracture SystemSummary page 5…em (#K042021) Equinoxe Fracture Humeral Adapter Tray (#K073688) Zimmer Anatomical Shoulder Fracture System (#¥K062029) Biomet Comprehensive Shoulder Fracture System (#K023063) Biomet Comprehensive Reverse Shoulder (#K080642) Tornier Aequalis Shoulder Fracture System & Aequalis Shoulder System (#K06020… | 2002 |
| * | K080642 | Comprehensive Reverse ShoulderSummary page 5…ray (#K073688) Zimmer Anatomical Shoulder Fracture System (#¥K062029) Biomet Comprehensive Shoulder Fracture System (#K023063) Biomet Comprehensive Reverse Shoulder (#K080642) Tornier Aequalis Shoulder Fracture System & Aequalis Shoulder System (#K060209) Tomnier Aequalis Shoulder Reversed Adapter (#K0… | 2008 |
| * | K060209 | Aequalis Shoulder Fracture System & Aequalis Shoulder SystemSummary page 5…mprehensive Shoulder Fracture System (#K023063) Biomet Comprehensive Reverse Shoulder (#K080642) Tornier Aequalis Shoulder Fracture System & Aequalis Shoulder System (#K060209) Tomnier Aequalis Shoulder Reversed Adapter (#K071948) ® © ®» @ & o o Device Description The Equinoxe Platform Fracture Stem i… | 2006 |
| * | K071948 | Aequalis Reversed AdapterSummary page 5…t Comprehensive Reverse Shoulder (#K080642) Tornier Aequalis Shoulder Fracture System & Aequalis Shoulder System (#K060209) Tomnier Aequalis Shoulder Reversed Adapter (#K071948) ® © ®» @ & o o Device Description The Equinoxe Platform Fracture Stem is a humeral stem for use in acute fracture of the prox… | 2007 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 25, 2020 | Class II | Z-0307-2021 | Process control | The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem. |
| Sep 25, 2020 | Class II | Z-0308-2021 | Process control | The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem. |
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 22 of the 79 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K131277 (Ingen Orthopedics, LLC, 2013) has gone furthest, with 0 descendants of its own.
- 13 other devices also cite its predicate K042021.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 to relieve pain and restore function 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. Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows: Rheumatoid arthritis, osteoarthritis, osteonecrosis or…
Read the full statement (314 words)
The Equinoxe Shoulder System is indicated to relieve pain and restore function 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.
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 arthodesis 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 to relieve pain and restore function
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 to relieve pain and restore function 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).
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/K092900 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092900: Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092900
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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