510(k) · Cleared
Recalled · Class II · 2021Aequalis 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 Jan 8, 2013 as substantially equivalent to K121493 (Tornier, Inc., 2012) and 1 other predicate after a 126-day review. Its family tree reaches back 13 generations to 1991. 1 of the 196 devices in its family, counting itself, has a Class I recall. 96 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 8, 2013
- Review
- 126 days
- Class
- Class II
- Product code
- KWS
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 13 generations to K911686 (1991). 99 ancestors in all, the oldest K790987 (1979). 96 later devices descend from it, 16 citing it directly. 1 of the 196 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 9 generations between
- 3 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 2 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 1 generation backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- This deviceK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013
- Descendant · cites it directly · 29 of its ownK140082 Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S. · 2014
- Descendant · cites it directly · 26 of its ownK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
- Descendant · cites it directly · 20 of its ownK163669 Humeris ShoulderFx Solutions · 2017
- Descendant · cites it directly · 20 of its ownK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
- Descendant · cites it directly · 19 of its ownK141990 Encore Humeral Shoulder StemEncore Medical L.P. · 2014 · Recalled
Show all 13 generations
- Root · 13 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 12 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 11 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 10 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 9 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 8 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 7 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 6 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 5 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 4 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 3 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 2 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 1 generation backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- This deviceK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013
Showing 5 of 96 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder3 generations back · 2008
Most influential descendants
Showing 5 of 96 · See all- K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S. · 2014 · cites it directly29descendants
- K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013 · cites it directly26descendants
- K163669Humeris ShoulderFx Solutions · 2017 · cites it directly20descendants
- K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2015 · cites it directly20descendants
- K141990Encore Humeral Shoulder StemEncore Medical L.P. · 2014 · cites it directly19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −12 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −11 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −10 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −9 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −8 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −7 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −6 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −5 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −4 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −3 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −2 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −1 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| 0 (this device) | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | — |
| +1 | K140082 | Aequalis (TM) Ascent (TM) Flex Shoulder System | Tornier S.A.S. | 2014 | — |
| +1 | K132285 | Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2013 | — |
| +1 | K163669 | Humeris Shoulder | Fx Solutions | 2017 | — |
| +1 | K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2015 | — |
| +1 | K141990 | Encore Humeral Shoulder Stem | Encore Medical L.P. | 2014 | 3 |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 7 | 0 |
| 2020 | 9 | 0 |
| 2021 | 9 | 0 |
| 2022 | 13 | 0 |
| 2023 | 10 | 0 |
| 2024 | 10 | 0 |
| 2025 | 12 | 0 |
| 2026 | 13 | 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 |
|---|---|---|---|
| * | K121493 | Ascend Shoulder SystemSummary page 5…panel: Orthopedic Product code: KWT; KWS; HSD; 5) Legally Marketed Device to which Equivalence is Claimed: Primary Predicates: ’ e Tornier Inc. Ascend Shoulder System (K121493; most recent) ¢ Tornier Inc. Aequalis Ascend Madular Reverse Shoulder System (K112615) Reference Predicate: * Tomier Inc. Aequal… | 2012 |
| * | K112615 | Aequalis Ascend Modular Reverse Shoulder SystemSummary page 5…uivalence is Claimed: Primary Predicates: ’ e Tornier Inc. Ascend Shoulder System (K121493; most recent) ¢ Tornier Inc. Aequalis Ascend Madular Reverse Shoulder System (K112615) Reference Predicate: * Tomier Inc. Aequalis® Adjustable Reverse Shoulder System (K120739) 6) Device description The Aequalis A… | 2011 |
| † | K120739 | Aequalis Adjustable Modular Reverse Shoulder System | 2012 |
What descends from it? (96)
See all 9616 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140082 | Aequalis (TM) Ascent (TM) Flex Shoulder System | 2014 | 29 |
| K132285 | Aequalis Reversed Shoulder Prosthesis | 2013 | 26 |
| K163669 | Humeris Shoulder | 2017 | 20 |
| K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis | 2015 | 20 |
| K141990 | Encore Humeral Shoulder Stem | 2014 | 19 |
| K190290 | AltiVate Reverse Humeral Stem, 48mm | 2019 | 15 |
| K202716 | Ignite Anatomic Shoulder System | 2021 | 13 |
| K191963 | SMR Finned Short Stems | 2019 | 13 |
| K190521 | Aequalis Ascend Flex Shoulder System | 2019 | 12 |
| K170910 | Medacta Anatomic Shoulder Prosthesis | 2017 | 8 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 28, 2021 | Class II | Z-2025-2021 | Employee error | Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness. |
| Oct 18, 2019 | Class II | Z-0405-2020 | Package design/selection | During shipping, it is possible for the Aequalis Ascend Flex humeral stem to become unseated or otherwise move within its internal packaging restraints. Movement within the packaging may cause the product to rub against the PETG blister… |
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 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 8 companies; a new generation was cleared every 9 months on median.
- 24 of the 99 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K140082 (Tornier S.A.S., 2014) has gone furthest, with 29 descendants of its own.
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. 2013, 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?
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…
Read the full statement (389 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.
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.
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/K122698 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122698: 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/K122698
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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