510(k) · Cleared
ClearedAequalis Adjustable Modular Reverse Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier, Inc. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Jul 5, 2012 as substantially equivalent to K102924 (Tornier, Inc., 2011) and 4 other predicates after a 115-day review. Its family tree reaches back 12 generations to 1991. 1 of the 108 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it.
- Decided
- Jul 5, 2012
- Review
- 115 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 12 generations to K911686 (1991). 95 ancestors in all, the oldest K790987 (1979). 12 later devices descend from it, 3 citing it directly. 1 of the 108 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 8 generations between
- 3 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 2 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 1 generation backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- This deviceK120739 Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc. · 2012
- Descendant · cites it directly · 9 of its ownK130050 Titan Reverse Shoulder SystemAscension Orthopedic · 2013
- Descendant · 2 generations on · 8 of its ownK161189 Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2016
- Descendant · 3 generations on · 4 of its ownK190588 Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2019
- Descendant · 3 generations on · 3 of its ownK173717 Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2018
- Descendant · 4 generations on · 2 of its ownK181999 Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2018
Show all 12 generations
- Root · 12 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 11 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 10 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 9 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 8 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 7 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 6 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 5 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 4 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 3 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 2 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 1 generation backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- This deviceK120739 Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc. · 2012
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder2 generations back · 2008
Most influential descendants
Showing 5 of 12 · See all- K130050Titan Reverse Shoulder SystemAscension Orthopedic · 2013 · cites it directly9descendants
- K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2016 · 2 generations on8descendants
- K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2019 · 3 generations on4descendants
- K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2018 · 3 generations on3descendants
- K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation · 2018 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −11 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −10 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −9 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −8 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −7 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −6 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −5 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −4 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −3 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −2 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −1 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| 0 (this device) | K120739 | Aequalis Adjustable Modular Reverse Shoulder System | Tornier, Inc. | 2012 | — |
| +1 | K130050 | Titan Reverse Shoulder System | Ascension Orthopedic | 2013 | — |
| +2 | K161189 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | 2016 | — |
| +3 | K190588 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | 2019 | — |
| +3 | K173717 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | 2018 | — |
| +4 | K181999 | Integra TITAN Reverse Shoulder System | Integra LifeSciences Corporation | 2018 | — |
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 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 6 | 0 |
| 2001 | 7 | 0 |
| 2002 | 1 | 0 |
| 2003 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 6 | 0 |
| 2006 | 9 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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? (5)
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 |
|---|---|---|---|
| * | K102924 | Aequalis Ascend Modular Anatomic Shoulder SystemSummary page 5…l: Orthopedic Product code: ’ KWT; KWS; HSD 5) Legally Marketed Device to which Equivalence is Claimed: Tornier Aéqualis Ascend Modular Anatomic Shoulder. Prosthesis: K102924 Tornier Aequalis® Ascend™ Modular Reverse Shoulder System K110599 Tornier Aequalis Reversed Shoulder Prosthesis: K081059 Tornier… | 2011 |
| * | K110599 | Aequalis Ascend Modular Reverse Shoulder SystemSummary page 5…Device to which Equivalence is Claimed: Tornier Aéqualis Ascend Modular Anatomic Shoulder. Prosthesis: K102924 Tornier Aequalis® Ascend™ Modular Reverse Shoulder System K110599 Tornier Aequalis Reversed Shoulder Prosthesis: K081059 Tornier Aequalis Reversed Shoulder Prosthesis (HAP Coated): K1 00142 Torn… | 2011 |
| * | K081059 | Aequalis Reversed Shoulder ProsthesisSummary page 5…is Ascend Modular Anatomic Shoulder. Prosthesis: K102924 Tornier Aequalis® Ascend™ Modular Reverse Shoulder System K110599 Tornier Aequalis Reversed Shoulder Prosthesis: K081059 Tornier Aequalis Reversed Shoulder Prosthesis (HAP Coated): K1 00142 Tornier Aequalis Reversed Fracture Shoulder Prosthesis: K08… | 2008 |
| * | K100142 | Aequalis Reversed Shoulder ProsthesisSummary page 5…alis® Ascend™ Modular Reverse Shoulder System K110599 Tornier Aequalis Reversed Shoulder Prosthesis: K081059 Tornier Aequalis Reversed Shoulder Prosthesis (HAP Coated): K1 00142 Tornier Aequalis Reversed Fracture Shoulder Prosthesis: K082120 6) Device description The Aequalis Adjustable Reverse Shoulder… | 2010 |
| * | K082120 | Aequalis Reversed Fracture Shoulder ProthesisSummary page 5…ualis Reversed Shoulder Prosthesis: K081059 Tornier Aequalis Reversed Shoulder Prosthesis (HAP Coated): K1 00142 Tornier Aequalis Reversed Fracture Shoulder Prosthesis: K082120 6) Device description The Aequalis Adjustable Reverse Shoulder system is a modular Reverse version of the Aequalis Shoulder Sys… | 2008 |
What descends from it? (12)
See all 123 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)
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 back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
- 24 of the 95 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K130050 (Ascension Orthopedic, 2013) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K102924.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Adjustable Reverse Shoulder System is indicated for patients with a functional deltoid muscle and a massive and non-repairable rotator cuff tear as a replacement of Shoulder joints disabled by: Rheumatoid arthritis with pain Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) Correction of functional deformity Fractures of the humeral head Traumatic arthritis Revision of the devices if sufficient bone…
Read the full statement (108 words)
The Aequalis Adjustable Reverse Shoulder System is indicated for patients with a functional deltoid muscle and a massive and non-repairable rotator cuff tear as a replacement of Shoulder joints disabled by:
Rheumatoid arthritis with pain
Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
Correction of functional deformity
Fractures of the humeral head
Traumatic arthritis
Revision of the devices if sufficient bone stock remains
Notes:
All components are single use
The humeral stems:
The uncoated humeral stems are for cemented or cementless use;
The hydroxylapatite coated stems are for cementless use only
The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.
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/K120739 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120739: Aequalis Adjustable Modular Reverse Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120739
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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