510(k) · Cleared
ClearedAequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis
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 Sep 24, 2015 as substantially equivalent to K122698 (Tornier S.A.S., 2013) and 13 other predicates after a 132-day review. Its family tree reaches back 15 generations to 1991. 1 of the 158 devices in its family, counting itself, has a Class I recall. 20 later devices descend from it.
- Decided
- Sep 24, 2015
- Review
- 132 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 14
Its longest line of descent runs back 15 generations to K911686 (1991). 137 ancestors in all, the oldest K790987 (1979). 20 later devices descend from it, 4 citing it directly. 1 of the 158 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 11 generations between
- 3 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 2 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 1 generation backK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
- This deviceK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
- Descendant · cites it directly · 12 of its ownK190521 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2019
- Descendant · 2 generations on · 11 of its ownK201315 PERFORM Humeral System – StemTornier, Inc. · 2020 · Recalled
- Descendant · cites it directly · 5 of its ownK220847 AETOS Shoulder SystemSmith & Nephew, Inc. · 2023
- Descendant · 2 generations on · 3 of its ownK240716 AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc. · 2024
- Descendant · 3 generations on · 2 of its ownK212800 PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A. · 2022 · Recalled
Show all 15 generations
- Root · 15 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 14 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 13 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 12 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 11 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 10 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 9 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 8 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 7 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 6 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 5 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 4 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 3 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 2 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 1 generation backK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
- This deviceK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
Showing 5 of 20 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 20 · See all- K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2019 · cites it directly12descendants
- K201315PERFORM Humeral System – StemTornier, Inc. · 2020 · 2 generations on11descendants
- K220847AETOS Shoulder SystemSmith & Nephew, Inc. · 2023 · cites it directly5descendants
- K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc. · 2024 · 2 generations on3descendants
- K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A. · 2022 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −14 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −13 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −12 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −11 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −10 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −9 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −8 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −7 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −6 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −5 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −4 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −3 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −2 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| −1 | K132285 | Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2013 | — |
| 0 (this device) | K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2015 | — |
| +1 | K190521 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2019 | — |
| +2 | K201315 | PERFORM Humeral System – Stem | Tornier, Inc. | 2020 | 1 |
| +1 | K220847 | AETOS Shoulder System | Smith & Nephew, Inc. | 2023 | — |
| +2 | K240716 | AETOS Shoulder System Stemless Humeral Prosthesis | Smith & Nephew, Inc. | 2024 | — |
| +3 | K212800 | PRIMA Humeral System and SMR Glenosphere Ø42 | Lima Corporate S.P.A. | 2022 | 2 |
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 |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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? (14)
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 6…el: Orthopedic Product code: PHX, KWS 5) Equivalent / Predicate device : Aequalis™ Ascend™ Flex Shoulder System : Aequalis Ascend Flex Shoulder System, Tornier K122698, K140082 Aequalis Reversed Shoulder Prosthesis, Tornier, K030941, K050316, K061439, K081059, K100142, K132285, K140478 Surgical R… | 2013 |
| * | K140082 | Aequalis (TM) Ascent (TM) Flex Shoulder SystemSummary page 6…pedic Product code: PHX, KWS 5) Equivalent / Predicate device : Aequalis™ Ascend™ Flex Shoulder System : Aequalis Ascend Flex Shoulder System, Tornier K122698, K140082 Aequalis Reversed Shoulder Prosthesis, Tornier, K030941, K050316, K061439, K081059, K100142, K132285, K140478 Surgical Reverse Sh… | 2014 |
| * | K030941 | Aequalis Reversed Shoulder ProsthesisSummary page 6…redicate device : Aequalis™ Ascend™ Flex Shoulder System : Aequalis Ascend Flex Shoulder System, Tornier K122698, K140082 Aequalis Reversed Shoulder Prosthesis, Tornier, K030941, K050316, K061439, K081059, K100142, K132285, K140478 Surgical Reverse Shoulder Prosthesis (RSP), DJO, K041066, K051075, K092873,… | 2004 |
| * | K050316 | Aequalis Reversed Shoulder ProsthesisSummary page 6…device : Aequalis™ Ascend™ Flex Shoulder System : Aequalis Ascend Flex Shoulder System, Tornier K122698, K140082 Aequalis Reversed Shoulder Prosthesis, Tornier, K030941, K050316, K061439, K081059, K100142, K132285, K140478 Surgical Reverse Shoulder Prosthesis (RSP), DJO, K041066, K051075, K092873, K112069,… | 2005 |
| * | K061439 | Aequalis Reversed ProsthesisSummary page 6…Aequalis™ Ascend™ Flex Shoulder System : Aequalis Ascend Flex Shoulder System, Tornier K122698, K140082 Aequalis Reversed Shoulder Prosthesis, Tornier, K030941, K050316, K061439, K081059, K100142, K132285, K140478 Surgical Reverse Shoulder Prosthesis (RSP), DJO, K041066, K051075, K092873, K112069, K140904… | 2006 |
| * | K081059 | Aequalis Reversed Shoulder ProsthesisSummary page 6…Ascend™ Flex Shoulder System : Aequalis Ascend Flex Shoulder System, Tornier K122698, K140082 Aequalis Reversed Shoulder Prosthesis, Tornier, K030941, K050316, K061439, K081059, K100142, K132285, K140478 Surgical Reverse Shoulder Prosthesis (RSP), DJO, K041066, K051075, K092873, K112069, K140904 Aequalis… | 2008 |
| * | K100142 | Aequalis Reversed Shoulder ProsthesisSummary page 6…Flex Shoulder System : Aequalis Ascend Flex Shoulder System, Tornier K122698, K140082 Aequalis Reversed Shoulder Prosthesis, Tornier, K030941, K050316, K061439, K081059, K100142, K132285, K140478 Surgical Reverse Shoulder Prosthesis (RSP), DJO, K041066, K051075, K092873, K112069, K140904 Aequalis Reversed… | 2010 |
| * | K132285 | Aequalis Reversed Shoulder ProsthesisSummary page 6…lder System : Aequalis Ascend Flex Shoulder System, Tornier K122698, K140082 Aequalis Reversed Shoulder Prosthesis, Tornier, K030941, K050316, K061439, K081059, K100142, K132285, K140478 Surgical Reverse Shoulder Prosthesis (RSP), DJO, K041066, K051075, K092873, K112069, K140904 Aequalis Reversed Shoulder… | 2013 |
| * | K140478 | Aequalis Reversed Shoulder ProsthesisSummary page 6…em : Aequalis Ascend Flex Shoulder System, Tornier K122698, K140082 Aequalis Reversed Shoulder Prosthesis, Tornier, K030941, K050316, K061439, K081059, K100142, K132285, K140478 Surgical Reverse Shoulder Prosthesis (RSP), DJO, K041066, K051075, K092873, K112069, K140904 Aequalis Reversed Shoulder Prosthes… | 2014 |
| * | K041066 | Encore Reverse Shoulder ProsthesisSummary page 6…8, K140082 Aequalis Reversed Shoulder Prosthesis, Tornier, K030941, K050316, K061439, K081059, K100142, K132285, K140478 Surgical Reverse Shoulder Prosthesis (RSP), DJO, K041066, K051075, K092873, K112069, K140904 Aequalis Reversed Shoulder Prosthesis : Aequalis Reversed Shoulder Prosthesis, TORNIER, K030… | 2005 |
| * | K051075 | Encore Reverse Shoulder ProsthesisSummary page 6…2 Aequalis Reversed Shoulder Prosthesis, Tornier, K030941, K050316, K061439, K081059, K100142, K132285, K140478 Surgical Reverse Shoulder Prosthesis (RSP), DJO, K041066, K051075, K092873, K112069, K140904 Aequalis Reversed Shoulder Prosthesis : Aequalis Reversed Shoulder Prosthesis, TORNIER, K030941, K050… | 2005 |
| * | K092873 | Reverse Shoulder ProsthesisSummary page 6…s Reversed Shoulder Prosthesis, Tornier, K030941, K050316, K061439, K081059, K100142, K132285, K140478 Surgical Reverse Shoulder Prosthesis (RSP), DJO, K041066, K051075, K092873, K112069, K140904 Aequalis Reversed Shoulder Prosthesis : Aequalis Reversed Shoulder Prosthesis, TORNIER, K030941, K050316, K061… | 2009 |
| * | K112069 | RSP Glenoid Baseplate Porous CoatedSummary page 6…d Shoulder Prosthesis, Tornier, K030941, K050316, K061439, K081059, K100142, K132285, K140478 Surgical Reverse Shoulder Prosthesis (RSP), DJO, K041066, K051075, K092873, K112069, K140904 Aequalis Reversed Shoulder Prosthesis : Aequalis Reversed Shoulder Prosthesis, TORNIER, K030941, K050316, K061439, K081… | 2011 |
| * | K140904 | RSP Monoblock Stem with P2 Coating, Size 6Summary page 6…r Prosthesis, Tornier, K030941, K050316, K061439, K081059, K100142, K132285, K140478 Surgical Reverse Shoulder Prosthesis (RSP), DJO, K041066, K051075, K092873, K112069, K140904 Aequalis Reversed Shoulder Prosthesis : Aequalis Reversed Shoulder Prosthesis, TORNIER, K030941, K050316, K061439, K081059, K100… | 2014 |
What descends from it? (20)
See all 204 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 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 33 of the 137 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K190521 (Tornier S.A.S., 2019) has gone furthest, with 12 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. 2015, 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…
Read the full statement (911 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 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 for cemented use only.
- the 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.
Device Name: Aequalis Reversed Shoulder Prosthesis
Indications For Use:
Cemented Aequalis Reversed prosthesis:
It 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 with the 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 again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
Uncemented Aequalis Reversed prosthesis:
It 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. The humeral components are for uncemented 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 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 in to a non reversed hemi-prosthesis.
When, in case of revision of an Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components.
Note:
- Titanium glenoid spheres 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 glenoid sphere 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/K151293 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151293: Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151293
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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