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 Jul 17, 2008 as substantially equivalent to K030941 (Tornier, 2004) and 7 other predicates after a 94-day review. Its family tree reaches back 8 generations to 1991. 179 later devices descend from it.
- Decided
- Jul 17, 2008
- Review
- 94 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 8 generations to K911686 (1991). 26 ancestors in all, the oldest K800494 (1980). 179 later devices descend from it, 9 citing it directly.
- Root · 8 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 7 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 6 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 5 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 4 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 3 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 2 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- 1 generation backK061439 Aequalis Reversed ProsthesisTornier · 2006
- This deviceK081059 Aequalis Reversed Shoulder ProsthesisTornier · 2008
- Descendant · cites it directly · 147 of its ownK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
- Descendant · 2 generations on · 108 of its ownK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- Descendant · 3 generations on · 97 of its ownK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- Descendant · 4 generations on · 96 of its ownK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- Descendant · cites it directly · 53 of its ownK161742 Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. · 2016 · Recalled
Showing 5 of 179 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 179 · See all- K100142Aequalis Reversed Shoulder ProsthesisTornier · 2010 · cites it directly147descendants
- K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 2 generations on108descendants
- K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 3 generations on97descendants
- K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · 4 generations on96descendants
- K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. · 2016 · cites it directly53descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −7 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −6 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −5 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −4 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −3 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −2 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
| −1 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| 0 (this device) | K081059 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2008 | — |
| +1 | K100142 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2010 | — |
| +2 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| +3 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| +4 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| +1 | K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid | Tornier, Inc. | 2016 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 8 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 11 | 0 |
| 2018 | 14 | 0 |
| 2019 | 15 | 0 |
| 2020 | 13 | 0 |
| 2021 | 18 | 0 |
| 2022 | 18 | 0 |
| 2023 | 14 | 0 |
| 2024 | 14 | 0 |
| 2025 | 15 | 0 |
| 2026 | 19 | 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? (8)
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 ProsthesisSummary page 4…fication Device class: Class I Classification panel: ~ Orthopedic Product code: KWS 5) Equivalent / Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873, K050316, K061439 Aequalis Shoulder System, TORNIER SA, K952928, K012212, K041339, K060209 6) Device description The A… | 2004 |
| * | K041873 | Aequalis Reversed Shoulder ProsthesisSummary page 4…Device class: Class I Classification panel: ~ Orthopedic Product code: KWS 5) Equivalent / Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873, K050316, K061439 Aequalis Shoulder System, TORNIER SA, K952928, K012212, K041339, K060209 6) Device description The Aequalis R… | 2004 |
| * | K050316 | Aequalis Reversed Shoulder ProsthesisSummary page 4…lass: Class I Classification panel: ~ Orthopedic Product code: KWS 5) Equivalent / Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873, K050316, K061439 Aequalis Shoulder System, TORNIER SA, K952928, K012212, K041339, K060209 6) Device description The Aequalis Reversed S… | 2005 |
| * | K061439 | Aequalis Reversed ProsthesisSummary page 4…ss I Classification panel: ~ Orthopedic Product code: KWS 5) Equivalent / Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873, K050316, K061439 Aequalis Shoulder System, TORNIER SA, K952928, K012212, K041339, K060209 6) Device description The Aequalis Reversed Shoulder P… | 2006 |
| * | K952928 | Aequalis Shoulder System for Total & Hemishoulder ApplicationsSummary page 4…t code: KWS 5) Equivalent / Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873, K050316, K061439 Aequalis Shoulder System, TORNIER SA, K952928, K012212, K041339, K060209 6) Device description The Aequalis Reversed Shoulder Prosthesis is intended to be used to relicve pa… | 1995 |
| * | K012212 | Modification to Aequalis Shoulder SystemSummary page 4…WS 5) Equivalent / Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873, K050316, K061439 Aequalis Shoulder System, TORNIER SA, K952928, K012212, K041339, K060209 6) Device description The Aequalis Reversed Shoulder Prosthesis is intended to be used to relicve pain and si… | 2001 |
| * | K041339 | Aequalis Shoulder SystemSummary page 4…uivalent / Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873, K050316, K061439 Aequalis Shoulder System, TORNIER SA, K952928, K012212, K041339, K060209 6) Device description The Aequalis Reversed Shoulder Prosthesis is intended to be used to relicve pain and significant… | 2004 |
| * | K060209 | Aequalis Shoulder Fracture System & Aequalis Shoulder SystemSummary page 4…/ Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K030941, K041873, K050316, K061439 Aequalis Shoulder System, TORNIER SA, K952928, K012212, K041339, K060209 6) Device description The Aequalis Reversed Shoulder Prosthesis is intended to be used to relicve pain and significant disabili… | 2006 |
What descends from it? (179)
See all 1799 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100142 | Aequalis Reversed Shoulder Prosthesis | 2010 | 147 |
| K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid | 2016 | 53 |
| K132285 | Aequalis Reversed Shoulder Prosthesis | 2013 | 26 |
| K112144 | Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis… | 2012 | 23 |
| K140478 | Aequalis Reversed Shoulder Prosthesis | 2014 | 21 |
| K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis | 2015 | 20 |
| K133349 | SMR TT Metal Back Glenoid | 2014 | 20 |
| K120739 | Aequalis Adjustable Modular Reverse Shoulder System | 2012 | 12 |
| K183077 | Delta Xtend Reverse Shoulder System | 2019 | 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 17 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 26 ancestors has a recall of any class.
- Of its descendants, K100142 (Tornier, 2010) has gone furthest, with 147 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. 2008, 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 Aequalis Reversed Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored…
Read the full statement (198 words)
The Aequalis Reversed Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.
When during the primary surgery the glenoid bone 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 humeral components in order to transform the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis.
When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to implant a base plate and a sphere of Aequalis Reversed range again, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis into a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
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/K081059 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081059: Aequalis Reversed Shoulder Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081059
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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