510(k) · Cleared
ClearedModification to Aequalis 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 Aug 15, 2001 after a 30-day review. The FDA summary names no predicate by number. 246 later devices descend from it.
- Decided
- Aug 15, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 0
246 later devices descend from it, 6 citing it directly.
- This deviceK012212 Modification to Aequalis Shoulder SystemTornier · 2001
- 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
- Descendant · 2 generations on · 164 of its ownK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- Descendant · 2 generations on · 147 of its ownK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
Showing 5 of 246 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 246 · See all- K061439Aequalis Reversed ProsthesisTornier · 2006 · cites it directly199descendants
- K081059Aequalis Reversed Shoulder ProsthesisTornier · 2008 · cites it directly179descendants
- K071948Aequalis Reversed AdapterTornier · 2007 · 2 generations on178descendants
- K082120Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008 · 2 generations on164descendants
- K100142Aequalis Reversed Shoulder ProsthesisTornier · 2010 · 2 generations on147descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012212 | Modification to Aequalis Shoulder System | Tornier | 2001 | — |
| +1 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| +1 | K081059 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2008 | — |
| +2 | K071948 | Aequalis Reversed Adapter | Tornier | 2007 | — |
| +2 | K082120 | Aequalis Reversed Fracture Shoulder Prothesis | Tornier | 2008 | — |
| +2 | K100142 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2010 | 7 | 0 |
| 2011 | 8 | 0 |
| 2012 | 6 | 0 |
| 2013 | 8 | 0 |
| 2014 | 12 | 0 |
| 2015 | 7 | 0 |
| 2016 | 9 | 0 |
| 2017 | 13 | 0 |
| 2018 | 20 | 0 |
| 2019 | 19 | 0 |
| 2020 | 17 | 0 |
| 2021 | 21 | 0 |
| 2022 | 21 | 0 |
| 2023 | 15 | 0 |
| 2024 | 17 | 0 |
| 2025 | 17 | 0 |
| 2026 | 20 | 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?
The FDA summary names no predicate by number.
What descends from it? (246)
See all 2466 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061439 | Aequalis Reversed Prosthesis | 2006 | 199 |
| K081059 | Aequalis Reversed Shoulder Prosthesis | 2008 | 179 |
| K042021 | Exactech Equinoxe Shoulder System | 2004 | 71 |
| 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?
- Of its descendants, K061439 (Tornier, 2006) has gone furthest, with 199 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.
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 glenchumeral joint; non-union humeral head fracture; displaced 4-part proximal humeral fractures; avascular necrogis of the humeral head; or other difficult management problems where arthrodesis or resectional arthroplasty are not acceptable.
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/K012212 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012212: Modification to Aequalis Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012212
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026