510(k) · Cleared
ClearedAscend Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Apr 13, 2012 as substantially equivalent to K113413 (Tornier, Inc., 2012) and 1 other predicate after a 29-day review. Its family tree reaches back 9 generations to 1980. 98 later devices descend from it.
- Decided
- Apr 13, 2012
- Review
- 29 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K800494 (1980). 51 ancestors in all. 98 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 5 generations between
- 3 generations backK061862 Axiom Orthopaedics Shoulder Resurfacing SystemAxiom Orthopaedics, Inc. · 2006
- 2 generations backK071147 Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc. · 2007
- 1 generation backK113413 Ascend Shoulder SystemTornier, Inc. · 2012
- This deviceK120794 Ascend Shoulder SystemTornier, Inc. · 2012
- Descendant · cites it directly · 97 of its ownK121493 Ascend Shoulder SystemTornier, Inc. · 2012
- Descendant · 2 generations on · 96 of its ownK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- Descendant · 3 generations on · 29 of its ownK140082 Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S. · 2014
- Descendant · 3 generations on · 26 of its ownK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
- Descendant · 3 generations on · 20 of its ownK163669 Humeris ShoulderFx Solutions · 2017
Show all 9 generations
- Root · 9 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 8 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- 7 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
- 6 generations backK010827 Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc. · 2001 · Recalled
- 5 generations backK031971 Global Cap Resurfacing Replacement ShoulderDePuy Orthopaedics, Inc. · 2003
- 4 generations backK033516 Depuy Global Cap HA Resurfacing Shoulder Humeral HeadsDePuy Orthopaedics, Inc. · 2003
- 3 generations backK061862 Axiom Orthopaedics Shoulder Resurfacing SystemAxiom Orthopaedics, Inc. · 2006
- 2 generations backK071147 Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc. · 2007
- 1 generation backK113413 Ascend Shoulder SystemTornier, Inc. · 2012
- This deviceK120794 Ascend Shoulder SystemTornier, Inc. · 2012
Showing 5 of 98 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 98 · See all- K121493Ascend Shoulder SystemTornier, Inc. · 2012 · cites it directly97descendants
- K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · 2 generations on96descendants
- K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S. · 2014 · 3 generations on29descendants
- K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013 · 3 generations on26descendants
- K163669Humeris ShoulderFx Solutions · 2017 · 3 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K800494 | New Jersey Hemiarthroplasty Sholder Pros | Depuy, Inc. | 1980 | — |
| −8 | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| −7 | K002998 | Biomet BI-Polar Shoulder System | Biomet, Inc. | 2000 | 1 |
| −6 | K010827 | Copeland MB/HA Resurfacing Humeral Heads | Biomet Orthopedics, Inc. | 2001 | 1 |
| −5 | K031971 | Global Cap Resurfacing Replacement Shoulder | DePuy Orthopaedics, Inc. | 2003 | — |
| −4 | K033516 | Depuy Global Cap HA Resurfacing Shoulder Humeral Heads | DePuy Orthopaedics, Inc. | 2003 | — |
| −3 | K061862 | Axiom Orthopaedics Shoulder Resurfacing System | Axiom Orthopaedics, Inc. | 2006 | — |
| −2 | K071147 | Nexa Orthopedics Total Shoulder System | Nexa Orthopedics, Inc. | 2007 | — |
| −1 | K113413 | Ascend Shoulder System | Tornier, Inc. | 2012 | — |
| 0 (this device) | K120794 | Ascend Shoulder System | Tornier, Inc. | 2012 | — |
| +1 | K121493 | Ascend Shoulder System | Tornier, Inc. | 2012 | — |
| +2 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| +3 | K140082 | Aequalis (TM) Ascent (TM) Flex Shoulder System | Tornier S.A.S. | 2014 | — |
| +3 | K132285 | Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2013 | — |
| +3 | K163669 | Humeris Shoulder | Fx Solutions | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1987 | 4 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 5 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2006 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 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.
Planning a device in KWS? 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 |
|---|---|---|---|
| * | K113413 | Ascend Shoulder SystemSummary page 2…roduct code: KWT; KWS; HSD; 5) Legally Marketed Device to which Equivalence is Claimed: * Primary Predicate: Tornier Ascend Shoulder System: K113413 * Secondary Predicate: Biomet Comprehensive Shoulder System: K060692 6) Device description The Ascend Shoulder Syst… | 2012 |
| * | K060692 | Comprehensive Primary Shoulder StemsSummary page 2…h Equivalence is Claimed: * Primary Predicate: Tornier Ascend Shoulder System: K113413 * Secondary Predicate: Biomet Comprehensive Shoulder System: K060692 6) Device description The Ascend Shoulder System consists of a humeral stem Titanium Plasma Spray (Ti PS) coated and un-coa… | 2006 |
What descends from it? (98)
See all 981 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121493 | Ascend Shoulder System | 2012 | 97 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 8 of the 51 ancestors have a recall of any class.
- Of its descendants, K121493 (Tornier, Inc., 2012) has gone furthest, with 97 descendants of its own.
- 2 other devices also cite its predicate K113413.
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. 2012, 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?
The Ascend Shoulder System consists of a humeral stem, a mating humneral head, and an optional polyethylene glenoid. The stem and head may be used by themselves, as a hemniarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The Ascend Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased…
Read the full statement (162 words)
The Ascend Shoulder System consists of a humeral stem, a mating humneral head, and an optional polyethylene glenoid. The stem and head may be used by themselves, as a hemniarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The Ascend 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 Ascend Shoulder System is indicated for use as a replacement of shoulder joints disable by:
* Rheumatoid arthritis with pain
* Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
* Correction of functional deformity
* Fractures of the humneral head
* Traumatic arthritis
* Revision of other devices if sufficient bone stock remains
All components are single use. The humneral stem is intended for cemented or cementless use, while the all polyethylene glenoid is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120794: Ascend 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/K120794
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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