510(k) · Cleared
ClearedAequalis Ascend Flex Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier S.A.S. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Jun 12, 2019 as substantially equivalent to K122698 (Tornier S.A.S., 2013) and 1 other predicate after a 100-day review. Its family tree reaches back 16 generations to 1991. 1 of the 151 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it.
- Decided
- Jun 12, 2019
- Review
- 100 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K911686 (1991). 138 ancestors in all, the oldest K790987 (1979). 12 later devices descend from it, 1 citing it directly. 1 of the 151 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 12 generations between
- 3 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 2 generations backK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
- 1 generation backK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
- This deviceK190521 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2019
- Descendant · cites it directly · 11 of its ownK201315 PERFORM Humeral System – StemTornier, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 2 of its ownK212800 PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A. · 2022 · Recalled
- Descendant · 2 generations on · 1 of its ownK241878 Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform…Stryker Corporation (Tornier, Inc.) · 2024
- Descendant · 2 generations on · 1 of its ownK240876 Identity Shoulder SystemZimmer, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK233712 PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A. · 2024
Show all 16 generations
- Root · 16 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 15 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 14 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 13 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 12 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 11 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 10 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 9 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 8 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 7 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 6 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 5 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 4 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 3 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 2 generations backK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
- 1 generation backK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
- This deviceK190521 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2019
Showing 5 of 12 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 12 · See all- K201315PERFORM Humeral System – StemTornier, Inc. · 2020 · cites it directly11descendants
- K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A. · 2022 · 2 generations on2descendants
- K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.) · 2024 · 2 generations on1descendant
- K240876Identity Shoulder SystemZimmer, Inc. · 2024 · 2 generations on1descendant
- K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A. · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −15 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −14 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −13 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −12 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −11 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −10 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −9 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −8 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −7 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −6 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −5 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −4 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −3 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| −2 | K132285 | Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2013 | — |
| −1 | K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2015 | — |
| 0 (this device) | K190521 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2019 | — |
| +1 | K201315 | PERFORM Humeral System – Stem | Tornier, Inc. | 2020 | 1 |
| +2 | K212800 | PRIMA Humeral System and SMR Glenosphere Ø42 | Lima Corporate S.P.A. | 2022 | 2 |
| +2 | K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral… | Stryker Corporation (Tornier, Inc.) | 2024 | — |
| +2 | K240876 | Identity Shoulder System | Zimmer, Inc. | 2024 | — |
| +3 | K233712 | PRIMA Humeral System; PRIMA TT Glenoid | Lima Corporate S.P.A. | 2024 | — |
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 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 2 | 0 |
| 1996 | 7 | 0 |
| 1997 | 2 | 0 |
| 1998 | 6 | 0 |
| 1999 | 5 | 0 |
| 2000 | 9 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 7 | 0 |
| 2006 | 11 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 KWS device
- #1 K220847 AETOS Shoulder Systemscore 21.1 · 16 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…semi-constrained cemented prosthesis. Product Codes: KWS, KWT, HSD, PHX Predicate Device Information Predicate: Aequalis™ Ascend™ Flex Shoulder System 510(k) Number: K122698, K151293 Device Description: The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints… | 2013 |
| * | K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisSummary page 5…strained cemented prosthesis. Product Codes: KWS, KWT, HSD, PHX Predicate Device Information Predicate: Aequalis™ Ascend™ Flex Shoulder System 510(k) Number: K122698, K151293 Device Description: The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints for patie… | 2015 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201315 | PERFORM Humeral System – Stem | 2020 | 11 |
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 28 years and passes through 8 companies; a new generation was cleared every 1.0 years on median.
- 33 of the 138 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K201315 (Tornier, Inc., 2020) has gone furthest, with 11 descendants of its own.
- 15 other devices also cite its predicate K122698.
How does its category compare?
All KWS devicesKWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · KWS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWS
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWS
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWS
2,281in 2025
MAUDE reports naming product code KWS, 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 | 2 | — | 21 | 158 |
| 2008 | 4 | 37 | 29 | 238 |
| 2009 | 4 | 108 | 0 | 294 |
| 2010 | 7 | 33 | 10 | 393 |
| 2011 | 11 | 90 | 11 | 486 |
| 2012 | 7 | 86 | 10 | 542 |
| 2013 | 12 | 120 | 0 | 818 |
| 2014 | 7 | 89 | 1 | 1,066 |
| 2015 | 8 | 129 | 0 | 1,170 |
| 2016 | 10 | 114 | 1 | 970 |
| 2017 | 7 | 120 | 4 | 1,681 |
| 2018 | 4 | 152 | 1 | 1,545 |
| 2019 | 9 | 106 | 2 | 1,728 |
| 2020 | 3 | 98 | 5 | 1,567 |
| 2021 | 5 | 151 | 0 | 1,358 |
| 2022 | 5 | 158 | 0 | 1,268 |
| 2023 | 4 | 250 | 2 | 1,750 |
| 2024 | 2 | — | 0 | 2,122 |
| 2025 | 3 | 97 | 0 | 2,281 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (287 words)
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.
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/K190521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190521: Aequalis Ascend 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/K190521
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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