510(k) · Cleared
ClearedAequalis Reversed 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 20, 2006 as substantially equivalent to K030941 (Tornier, 2004) and 7 other predicates after a 57-day review. Its family tree reaches back 7 generations to 1991. 199 later devices descend from it.
- Decided
- Jul 20, 2006
- Review
- 57 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 7 generations to K911686 (1991). 25 ancestors in all, the oldest K800494 (1980). 199 later devices descend from it, 10 citing it directly.
- Root · 7 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 6 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 5 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 4 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 3 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 2 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 1 generation backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- This deviceK061439 Aequalis Reversed ProsthesisTornier · 2006
- Descendant · cites it directly · 179 of its ownK081059 Aequalis Reversed Shoulder ProsthesisTornier · 2008
- Descendant · cites it directly · 178 of its ownK071948 Aequalis Reversed AdapterTornier · 2007
- Descendant · cites it directly · 164 of its ownK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 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
Showing 5 of 199 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 199 · See all- K081059Aequalis Reversed Shoulder ProsthesisTornier · 2008 · cites it directly179descendants
- K071948Aequalis Reversed AdapterTornier · 2007 · cites it directly178descendants
- K082120Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008 · cites it directly164descendants
- K100142Aequalis Reversed Shoulder ProsthesisTornier · 2010 · cites it directly147descendants
- K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 2 generations on108descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −6 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −5 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −4 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −3 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −2 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −1 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
| 0 (this device) | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| +1 | K081059 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2008 | — |
| +1 | K071948 | Aequalis Reversed Adapter | Tornier | 2007 | — |
| +1 | K082120 | Aequalis Reversed Fracture Shoulder Prothesis | Tornier | 2008 | — |
| +1 | K100142 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2010 | — |
| +2 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 10 | 0 |
| 2015 | 4 | 0 |
| 2016 | 6 | 0 |
| 2017 | 12 | 0 |
| 2018 | 14 | 0 |
| 2019 | 16 | 0 |
| 2020 | 16 | 0 |
| 2021 | 20 | 0 |
| 2022 | 19 | 0 |
| 2023 | 15 | 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 1…nel: Orthopedic Product code: KWS 5) Equivalent I Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K03094 1, K041873, K050316 Aequalis Shoulder System, TORNIER SA, K952928, K0 12212, K041339, K060209 Delta Shoulder, DePuy hic,… | 2004 |
| * | K041873 | Aequalis Reversed Shoulder ProsthesisSummary page 1…Orthopedic Product code: KWS 5) Equivalent I Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K03094 1, K041873, K050316 Aequalis Shoulder System, TORNIER SA, K952928, K0 12212, K041339, K060209 Delta Shoulder, DePuy hic, K021478… | 2004 |
| * | K050316 | Aequalis Reversed Shoulder ProsthesisSummary page 1…Orthopedic Product code: KWS 5) Equivalent I Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K03094 1, K041873, K050316 Aequalis Shoulder System, TORNIER SA, K952928, K0 12212, K041339, K060209 Delta Shoulder, DePuy hic, K021478 6) D… | 2005 |
| * | K952928 | Aequalis Shoulder System for Total & Hemishoulder ApplicationsSummary page 1…KWS 5) Equivalent I Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K03094 1, K041873, K050316 Aequalis Shoulder System, TORNIER SA, K952928, K0 12212, K041339, K060209 Delta Shoulder, DePuy hic, K021478 6) Device description The Aequalis Reversed Should… | 1995 |
| * | K012212 | Modification to Aequalis Shoulder SystemSummary page 1…5) Equivalent I Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K03094 1, K041873, K050316 Aequalis Shoulder System, TORNIER SA, K952928, K0 12212, K041339, K060209 Delta Shoulder, DePuy hic, K021478 6) Device description The Aequalis Reversed Shoulder Prosthe… | 2001 |
| * | K041339 | Aequalis Shoulder SystemSummary page 1…alent I Predicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K03094 1, K041873, K050316 Aequalis Shoulder System, TORNIER SA, K952928, K0 12212, K041339, K060209 Delta Shoulder, DePuy hic, K021478 6) Device description The Aequalis Reversed Shoulder Prosthesisis int… | 2004 |
| * | K060209 | Aequalis Shoulder Fracture System & Aequalis Shoulder SystemSummary page 1…redicate device Aequalis Reversed Shoulder Prosthesis, TORNIER SA, K03094 1, K041873, K050316 Aequalis Shoulder System, TORNIER SA, K952928, K0 12212, K041339, K060209 Delta Shoulder, DePuy hic, K021478 6) Device description The Aequalis Reversed Shoulder Prosthesisis intended to… | 2006 |
| * | K021478 | Delta ShoulderSummary page 1…houlder Prosthesis, TORNIER SA, K03094 1, K041873, K050316 Aequalis Shoulder System, TORNIER SA, K952928, K0 12212, K041339, K060209 Delta Shoulder, DePuy hic, K021478 6) Device description The Aequalis Reversed Shoulder Prosthesisis intended to be used to relieve pain and significant… | 2003 |
What descends from it? (199)
See all 19910 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081059 | Aequalis Reversed Shoulder Prosthesis | 2008 | 179 |
| K071948 | Aequalis Reversed Adapter | 2007 | 178 |
| K082120 | Aequalis Reversed Fracture Shoulder Prothesis | 2008 | 164 |
| K100142 | Aequalis Reversed Shoulder Prosthesis | 2010 | 147 |
| 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 |
| K252788 | Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) | 2026 | 0 |
| 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 15 years and passes through 3 companies; a new generation was cleared every 7 months on median.
- 1 of the 25 ancestors has a recall of any class.
- Of its descendants, K081059 (Tornier, 2008) has gone furthest, with 179 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 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 as stated in the FDA summary.
https://510kreport.com/device/K061439 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061439: Aequalis Reversed Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061439
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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