510(k) · Cleared
ClearedAequalis (TM) Ascent (TM) Flex Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier S.A.S. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Jul 18, 2014 as substantially equivalent to K122698 (Tornier S.A.S., 2013) and 1 other predicate after a 186-day review. Its family tree reaches back 14 generations to 1991. 1 of the 130 devices in its family, counting itself, has a Class I recall. 29 later devices descend from it.
- Decided
- Jul 18, 2014
- Review
- 186 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K911686 (1991). 100 ancestors in all, the oldest K790987 (1979). 29 later devices descend from it, 4 citing it directly. 1 of the 130 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 10 generations between
- 3 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 2 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 1 generation backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- This deviceK140082 Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S. · 2014
- Descendant · cites it directly · 20 of its ownK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
- Descendant · 2 generations on · 12 of its ownK190521 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2019
- Descendant · 3 generations on · 11 of its ownK201315 PERFORM Humeral System – StemTornier, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 5 of its ownK220847 AETOS Shoulder SystemSmith & Nephew, Inc. · 2023
- Descendant · cites it directly · 4 of its ownK181420 Aequalis Flex Revive Shoulder SystemTornier, Inc. · 2018
Show all 14 generations
- Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 13 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 12 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 11 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 10 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 9 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 8 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 7 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 6 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 5 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 4 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 3 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 2 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 1 generation backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- This deviceK140082 Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S. · 2014
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder4 generations back · 2008
Most influential descendants
Showing 5 of 29 · See all- K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2015 · cites it directly20descendants
- K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2019 · 2 generations on12descendants
- K201315PERFORM Humeral System – StemTornier, Inc. · 2020 · 3 generations on11descendants
- K220847AETOS Shoulder SystemSmith & Nephew, Inc. · 2023 · 2 generations on5descendants
- K181420Aequalis Flex Revive Shoulder SystemTornier, Inc. · 2018 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −13 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −12 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −11 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −10 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −9 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −8 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −7 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −6 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −5 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −4 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −3 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −2 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −1 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| 0 (this device) | K140082 | Aequalis (TM) Ascent (TM) Flex Shoulder System | Tornier S.A.S. | 2014 | — |
| +1 | K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2015 | — |
| +2 | K190521 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2019 | — |
| +3 | K201315 | PERFORM Humeral System – Stem | Tornier, Inc. | 2020 | 1 |
| +2 | K220847 | AETOS Shoulder System | Smith & Nephew, Inc. | 2023 | — |
| +1 | K181420 | Aequalis Flex Revive Shoulder System | Tornier, Inc. | 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 |
| 2012 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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? (2)
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 |
|---|---|---|---|
| * | K122698 | Aequalis Ascend Flex Shoulder SystemSummary page 5…ice class: Classe Il Classification panel: Orthopedic Praduct code: KWT; KWS; HSD: 5) Equivalent/ Predicate device Tornier SAS: Aequalis™ Ascend™ Flex Shoulder System (K122698) Tornier SAS: Aequalis® Shoulder System (K952928) Tomier Section 3 K 140082 Page 2 of 5 6) Device description T… | 2013 |
| * | K952928 | Aequalis Shoulder System for Total & Hemishoulder ApplicationsSummary page 5…dic Praduct code: KWT; KWS; HSD: 5) Equivalent/ Predicate device Tornier SAS: Aequalis™ Ascend™ Flex Shoulder System (K122698) Tornier SAS: Aequalis® Shoulder System (K952928) Tomier Section 3 K 140082 Page 2 of 5 6) Device description The Aequalis Ascend Flex Shoulder System consists o… | 1995 |
What descends from it? (29)
See all 294 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis | 2015 | 20 |
| K181420 | Aequalis Flex Revive Shoulder System | 2018 | 4 |
| K180089 | Medacta Shoulder System Short Humeral Diaphysis | 2018 | 3 |
| K182799 | Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads | 2019 | 0 |
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 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 8 companies; a new generation was cleared every 1.0 years on median.
- 25 of the 100 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K151293 (Tornier S.A.S., 2015) has gone furthest, with 20 descendants of its own.
- 15 other devices also cite its predicate K122698.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
SYSTEM INTENDED USE: The Aequalis Ascend Flex Shoulder System is intended for use as: • A replacement of shoulder joints in primary anatomic or in primary reverse. • A replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains. • The Aequalis Ascend Flex Shoulder System also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision. IN ANATOMIC: The stem and head may be used by…
Read the full statement (445 words)
SYSTEM INTENDED USE:
The Aequalis Ascend Flex Shoulder System is intended for use as:
• A replacement of shoulder joints in primary anatomic or in primary reverse.
• A replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains.
• The Aequalis Ascend Flex Shoulder System also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.
IN ANATOMIC: The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.
The Aequalis Ascend Flex Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.
The Aequalis Ascend Flex Shoulder System is indicated for use 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 other devices if sufficient bone stock remains
IN REVERSE: The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by: Rheumatoid arthritis; 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.
The reversed adapter is indicated for use as components of the Aequalis Ascend Flex Shoulder System total shoulder replacement and for transformation of the Aequalis Ascend Flex Shoulder System into a reverse shoulder prosthesis without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The components are permitted to be used in the transformation from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthropathy is associated with a massive and non-repairable rotator cuff-tear.
Notes: All components are single use; The coated humeral stem is intended for cemented or cementless use; The non-coated humeral stem is intended for cemented use only; All poly glenoid components are intended for cemented use only; The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.; Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.
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/K140082 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140082: Aequalis (TM) Ascent (TM) Flex 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/K140082
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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