510(k) · Cleared
ClearedAequalis Reversed Shoulder Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Aug 25, 2004 as substantially equivalent to K030941 (Tornier, 2004) and 3 other predicates after a 44-day review. Its family tree reaches back 5 generations to 1991. 1 of the 290 devices in its family, counting itself, has a Class I recall. 277 later devices descend from it.
- Decided
- Aug 25, 2004
- Review
- 44 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K911686 (1991). 12 ancestors in all, the oldest K800494 (1980). 277 later devices descend from it, 13 citing it directly. 1 of the 290 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 4 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 3 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 2 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 1 generation backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- This deviceK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- Descendant · cites it directly · 248 of its ownK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- Descendant · cites it directly · 239 of its ownK053274 Anatomical Shoulder Inverse/ReverseZimmer GmbH · 2006 · Recalled
- Descendant · cites it directly · 216 of its ownK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 207 of its ownK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- Descendant · cites it directly · 199 of its ownK061439 Aequalis Reversed ProsthesisTornier · 2006
Showing 5 of 277 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder2 generations on · 2008
Most influential descendants
Showing 5 of 277 · See all- K050316Aequalis Reversed Shoulder ProsthesisTornier · 2005 · cites it directly248descendants
- K053274Anatomical Shoulder Inverse/ReverseZimmer GmbH · 2006 · cites it directly239descendants
- K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · cites it directly216descendants
- K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · 2 generations on207descendants
- K061439Aequalis Reversed ProsthesisTornier · 2006 · cites it directly199descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −4 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −3 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −2 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −1 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| 0 (this device) | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| +1 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
| +1 | K053274 | Anatomical Shoulder Inverse/Reverse | Zimmer GmbH | 2006 | 3 |
| +1 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| +2 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| +1 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 6 | 1 |
| 2010 | 6 | 0 |
| 2011 | 9 | 0 |
| 2012 | 14 | 0 |
| 2013 | 14 | 0 |
| 2014 | 13 | 0 |
| 2015 | 7 | 0 |
| 2016 | 10 | 0 |
| 2017 | 16 | 0 |
| 2018 | 19 | 0 |
| 2019 | 17 | 0 |
| 2020 | 20 | 0 |
| 2021 | 25 | 0 |
| 2022 | 19 | 0 |
| 2023 | 16 | 0 |
| 2024 | 17 | 0 |
| 2025 | 16 | 0 |
| 2026 | 24 | 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? (4)
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 |
|---|---|---|---|
| * | K030941 | Aequalis Reversed Shoulder Prosthesis | 2004 |
| * | K952928 | Aequalis Shoulder System for Total & Hemishoulder ApplicationsSummary page 1…semi-constrained cemented prosthesis. 5) Equivalent / Predicate device Aequalis Reversed Shoulder Prosthesis, TORNLER SA, K03094 I Aequalis Shoulder System, TORNIER SA, K952928 Bipolar Shoulder Prosthesis, BIOMET Inc, K991585 Delta Shoulder, DePuy Tne, K021478 6) Device description The Aequalis Reversed… | 1995 |
| * | K991585 | Bipolar Shoulder ProsthesisSummary page 1…ent / Predicate device Aequalis Reversed Shoulder Prosthesis, TORNLER SA, K03094 I Aequalis Shoulder System, TORNIER SA, K952928 Bipolar Shoulder Prosthesis, BIOMET Inc, K991585 Delta Shoulder, DePuy Tne, K021478 6) Device description The Aequalis Reversed Shoulder Prosthesis is intended to be used to rel… | 1999 |
| * | K021478 | Delta ShoulderSummary page 1…ersed Shoulder Prosthesis, TORNLER SA, K03094 I Aequalis Shoulder System, TORNIER SA, K952928 Bipolar Shoulder Prosthesis, BIOMET Inc, K991585 Delta Shoulder, DePuy Tne, K021478 6) Device description The Aequalis Reversed Shoulder Prosthesis is intended to be used to relieve pain and significant disabilit… | 2003 |
What descends from it? (277)
See all 27713 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050316 | Aequalis Reversed Shoulder Prosthesis | 2005 | 248 |
| K053274 | Anatomical Shoulder Inverse/Reverse | 2006 | 239 |
| K052906 | Zimmer Trabecular Metal Reverse Shoulder System | 2005 | 216 |
| K061439 | Aequalis Reversed Prosthesis | 2006 | 199 |
| K063569 | Equinoxe Reverse Shoulder System | 2007 | 190 |
| K081059 | Aequalis Reversed Shoulder Prosthesis | 2008 | 179 |
| K071948 | Aequalis Reversed Adapter | 2007 | 178 |
| K072804 | Comprehensive RS Shoulder System | 2007 | 175 |
| K082120 | Aequalis Reversed Fracture Shoulder Prothesis | 2008 | 164 |
| K100142 | Aequalis Reversed Shoulder Prosthesis | 2010 | 147 |
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 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 6 months on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K050316 (Tornier, 2005) has gone furthest, with 248 descendants of its own.
- 16 other devices also cite its predicate K030941.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Aequalis Reversed Shoulder Prosthesis is indicated for patients, with a runctional deltoid muscle, as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. The Aequalis Reversed Shoulder Prosfhesis humeral component is intended for cemented…
Read the full statement (199 words)
The Aequalis Reversed Shoulder Prosthesis is indicated for patients, with a runctional deltoid muscle, as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear.
The Aequalis Reversed Shoulder Prosfhesis humeral component is intended for cemented use only and the glenoid component is intended for non cemented use with 4 screws for fixation.
When during the primary surgery the glenoid stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the hurneral components in order to transform the Reversed prosthesis in to a non reversed hemi-prosthesis_ When, in case of revision of a Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Reversed prosthesis in to an anatomical non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041873 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041873: Aequalis Reversed Shoulder Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041873
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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