510(k) · Cleared
ClearedAequalis Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Jun 17, 2004 as substantially equivalent to K952928 (Tornier, 1995) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 1995. 259 later devices descend from it.
- Decided
- Jun 17, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K952928 (1995). 2 ancestors in all. 259 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK952928 Aequalis Shoulder System for Total & Hemishoulder ApplicationsTornier · 1995
- This deviceK041339 Aequalis Shoulder SystemTornier · 2004
- Descendant · cites it directly · 258 of its ownK043077 Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder…Tornier · 2004
- Descendant · cites it directly · 257 of its ownK060209 Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier · 2006
- Descendant · cites it directly · 199 of its ownK061439 Aequalis Reversed ProsthesisTornier · 2006
- Descendant · cites it directly · 179 of its ownK081059 Aequalis Reversed Shoulder ProsthesisTornier · 2008
- Descendant · 2 generations on · 178 of its ownK071948 Aequalis Reversed AdapterTornier · 2007
Showing 5 of 259 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 259 · See all- K043077Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder SystemTornier · 2004 · cites it directly258descendants
- K060209Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier · 2006 · cites it directly257descendants
- K061439Aequalis Reversed ProsthesisTornier · 2006 · cites it directly199descendants
- K081059Aequalis Reversed Shoulder ProsthesisTornier · 2008 · cites it directly179descendants
- K071948Aequalis Reversed AdapterTornier · 2007 · 2 generations on178descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952928 | Aequalis Shoulder System for Total & Hemishoulder Applications | Tornier | 1995 | — |
| 0 (this device) | K041339 | Aequalis Shoulder System | Tornier | 2004 | — |
| +1 | K043077 | Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System | Tornier | 2004 | — |
| +1 | K060209 | Aequalis Shoulder Fracture System & Aequalis Shoulder System | Tornier | 2006 | — |
| +1 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| +1 | K081059 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2008 | — |
| +2 | K071948 | Aequalis Reversed Adapter | Tornier | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 10 | 0 |
| 2012 | 7 | 0 |
| 2013 | 8 | 0 |
| 2014 | 11 | 0 |
| 2015 | 6 | 0 |
| 2016 | 12 | 0 |
| 2017 | 14 | 0 |
| 2018 | 17 | 0 |
| 2019 | 20 | 0 |
| 2020 | 18 | 0 |
| 2021 | 22 | 0 |
| 2022 | 22 | 0 |
| 2023 | 17 | 0 |
| 2024 | 16 | 0 |
| 2025 | 21 | 0 |
| 2026 | 22 | 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 |
|---|---|---|---|
| * | K952928 | Aequalis Shoulder System for Total & Hemishoulder ApplicationsSummary page 1…t code: KWS § 88823660 Shoulderjoint metal/polymer semi-constrained cemented prosthesis. 5) Equivalent /Predicate device AEQUALIS Shoulder system, TORNIER SA (K952928) Select Shoulder CoCr Humneral stem, Intermedics Orthopedics Inc, (K9623 15)… | 1995 |
| * | K962315 | Select Shoulder Cocr Humeral Stem ComponentSummary page 1…ed cemented prosthesis. 5) Equivalent /Predicate device AEQUALIS Shoulder system, TORNIER SA (K952928) Select Shoulder CoCr Humneral stem, Intermedics Orthopedics Inc, (K9623 15) Page I/ page 2… | 1996 |
What descends from it? (259)
See all 2597 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043077 | Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System | 2004 | 258 |
| K060209 | Aequalis Shoulder Fracture System & Aequalis Shoulder System | 2006 | 257 |
| K061439 | Aequalis Reversed Prosthesis | 2006 | 199 |
| K081059 | Aequalis Reversed Shoulder Prosthesis | 2008 | 179 |
| K081707 | Aequalis Shoulder Fracture and Shoulder Systems | 2008 | 25 |
| K112144 | Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis… | 2012 | 23 |
| K062661 | Aequalis Resurfacing Head | 2006 | 16 |
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?
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.
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?
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; non-union humeral head fracture; displaced 3-and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult management problems where arthrodesis or resectional arthroplasty are not acceptable.
The AEQUALIS Shoulder System is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041339 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041339: Aequalis 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/K041339
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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