510(k) · Cleared
Recalled · Class II · 2018Exactech® Equinoxe® Preserve 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 Feb 1, 2017 as substantially equivalent to K060692 (Biomet Manufacturing Corp, 2006) and 2 other predicates after a 125-day review. Its family tree reaches back 11 generations to 1991. 1 of the 77 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled once.
- Decided
- Feb 1, 2017
- Review
- 125 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 11 generations to K911686 (1991). 73 ancestors in all, the oldest K790987 (1979). 3 later devices descend from it, 1 citing it directly. 1 of the 77 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 deviceK162726 Exactech® Equinoxe® Preserve StemExactech, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK202024 ARROW Short Stem Humeral SystemFH Industrie · 2021
- Descendant · 2 generations on · 1 of its ownK253345 JARVIS Diaphyseal Stem StandardFH Industrie · 2025
- Descendant · 2 generations on · 0 of its ownK254003 JARVIS Metaphyseal StemFH Industrie · 2026
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 deviceK162726 Exactech® Equinoxe® Preserve StemExactech, Inc. · 2017
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulderdirect predicate · 2008
Most influential descendants
Showing 3 of 3 · 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) | K162726 | Exactech® Equinoxe® Preserve Stem | Exactech, Inc. | 2017 | — |
| +1 | K202024 | ARROW Short Stem Humeral System | FH Industrie | 2021 | — |
| +2 | K253345 | JARVIS Diaphyseal Stem Standard | FH Industrie | 2025 | — |
| +2 | K254003 | JARVIS Metaphyseal Stem | FH Industrie | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 4 | 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 | 3 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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.
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? (3)
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 |
|---|---|---|---|
| * | K060692 | Comprehensive Primary Shoulder StemsSummary page 4…II, Product code KWT Legally Marketed Device to Which Substantial Equivalence Is Claimed: • Biomet Comprehensive Primary Shoulder Micro Stem (K060692) • Exactech Equinoxe Press-Fit Primary Humeral Stem (K042021) • Biomet Comprehensive Reverse Shoulder (K080642) Device Des… | 2006 |
| * | K042021 | Exactech Equinoxe Shoulder SystemSummary page 4…evice to Which Substantial Equivalence Is Claimed: • Biomet Comprehensive Primary Shoulder Micro Stem (K060692) • Exactech Equinoxe Press-Fit Primary Humeral Stem (K042021) • Biomet Comprehensive Reverse Shoulder (K080642) Device Description The Exactech Equinoxe Preserve Stem is a line extension… | 2004 |
| * | K080642 | Comprehensive Reverse ShoulderSummary page 4…• Biomet Comprehensive Primary Shoulder Micro Stem (K060692) • Exactech Equinoxe Press-Fit Primary Humeral Stem (K042021) • Biomet Comprehensive Reverse Shoulder (K080642) Device Description The Exactech Equinoxe Preserve Stem is a line extension to the range of humeral stems marketed by Exactech u… | 2008 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202024 | ARROW Short Stem Humeral System | 2021 | 2 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 5, 2018 | Class II | Z-0958-2019 | Packaging | Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently packaged with an Optetrak Knee System instructions for use (IFU) rather than the Equinoxe Preserve Humeral Stem IFU as intended . |
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 26 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 22 of the 73 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K202024 (FH Industrie, 2021) has gone furthest, with 2 descendants of its own.
- 14 other devices also cite its predicate K060692.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total arthroplasty, anatomic hemi-arthroplasty, or reverse total arthroplasty is determined by the surgeon to be the preferred method of treatment. Clinical indications for anatomic total arthroplasty and anatomic hemi-arthroplasty are as follows: • Rheumatoid arthritis, osteoarthritis, osteonecrosis or…
Read the full statement (212 words)
The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total arthroplasty, anatomic hemi-arthroplasty, or reverse total arthroplasty is determined by the surgeon to be the preferred method of treatment.
Clinical indications for anatomic total arthroplasty and anatomic hemi-arthroplasty 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.
• 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)
• To restore mobility from previous procedures (e.g. previous fusion)
The Equinoxe Preserve Stems are additionally indicated for use in reverse total arthroplasty in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff or a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
The Equinoxe Preserve Stems are intended for press-fit applications but may be used with bone cement at the discretion of the surgeon.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162726 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162726: Exactech® Equinoxe® Preserve Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162726
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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