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 Nov 3, 2011 as substantially equivalent to K952928 (Tornier, 1995) and 5 other predicates after a 121-day review. Its family tree reaches back 6 generations to 1993. 49 later devices descend from it.
- Decided
- Nov 3, 2011
- Review
- 121 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K920362 (1993). 26 ancestors in all, the oldest K873679 (1987). 49 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK920362 3M Modular Shoulder System3M Health Care, Ltd. · 1993
- 5 generations backK002683 WMT Ultra-Fit Modular Shoulder SystemWrightmedicaltechnologyinc · 2000
- 4 generations backK032679 Aequalis Shoulder Fracture SystemTornier · 2003
- 3 generations backK043077 Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder…Tornier · 2004
- 2 generations backK060209 Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier · 2006
- 1 generation backK063081 Aequalis Shoulder SystemTornier · 2006
- This deviceK111902 Aequalis Shoulder SystemTornier · 2011
- Descendant · cites it directly · 31 of its ownK143374 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015
- Descendant · 2 generations on · 25 of its ownK160555 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016
- Descendant · 3 generations on · 23 of its ownK162800 BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017
- Descendant · 4 generations on · 18 of its ownK203315 BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2021
- Descendant · cites it directly · 16 of its ownK150583 Aequalis PerFORM+ Shoulder SystemTornier, Inc. · 2015
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2015 · cites it directly31descendants
- K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2016 · 2 generations on25descendants
- K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S. · 2017 · 3 generations on23descendants
- K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S. · 2021 · 4 generations on18descendants
- K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc. · 2015 · cites it directly16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K920362 | 3M Modular Shoulder System | 3M Health Care, Ltd. | 1993 | — |
| −5 | K002683 | WMT Ultra-Fit Modular Shoulder System | Wrightmedicaltechnologyinc | 2000 | — |
| −4 | K032679 | Aequalis Shoulder Fracture System | Tornier | 2003 | — |
| −3 | K043077 | Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System | Tornier | 2004 | — |
| −2 | K060209 | Aequalis Shoulder Fracture System & Aequalis Shoulder System | Tornier | 2006 | — |
| −1 | K063081 | Aequalis Shoulder System | Tornier | 2006 | — |
| 0 (this device) | K111902 | Aequalis Shoulder System | Tornier | 2011 | — |
| +1 | K143374 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2015 | — |
| +2 | K160555 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2016 | — |
| +3 | K162800 | BLUEPRINT Patient Specific Instrumentation | Tornier S.A.S. | 2017 | — |
| +4 | K203315 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | 2021 | — |
| +1 | K150583 | Aequalis PerFORM+ Shoulder System | Tornier, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 6 | 0 |
| 2025 | 9 | 0 |
| 2026 | 8 | 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? (6)
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…Class 11 Classification panel: Orthopedic Product code: KWS 6) Equivalent / Predicate device Aequalls Shoulder System, Tornia, K952928, K994392, K060209 and K063081 Affiniti Total and Hemi-Shoulder System, Tornier, Inc., K060988 and K103007… | 1995 |
| * | K994392 | Aequalis Shoulder Fracture SystemSummary page 1…ss 11 Classification panel: Orthopedic Product code: KWS 6) Equivalent / Predicate device Aequalls Shoulder System, Tornia, K952928, K994392, K060209 and K063081 Affiniti Total and Hemi-Shoulder System, Tornier, Inc., K060988 and K103007… | 2000 |
| * | K060209 | Aequalis Shoulder Fracture System & Aequalis Shoulder SystemSummary page 1…lassification panel: Orthopedic Product code: KWS 6) Equivalent / Predicate device Aequalls Shoulder System, Tornia, K952928, K994392, K060209 and K063081 Affiniti Total and Hemi-Shoulder System, Tornier, Inc., K060988 and K103007… | 2006 |
| * | K063081 | Aequalis Shoulder SystemSummary page 1…n panel: Orthopedic Product code: KWS 6) Equivalent / Predicate device Aequalls Shoulder System, Tornia, K952928, K994392, K060209 and K063081 Affiniti Total and Hemi-Shoulder System, Tornier, Inc., K060988 and K103007… | 2006 |
| * | K060988 | Total and Hemi Shoulder SystemSummary page 1…S 6) Equivalent / Predicate device Aequalls Shoulder System, Tornia, K952928, K994392, K060209 and K063081 Affiniti Total and Hemi-Shoulder System, Tornier, Inc., K060988 and K103007 Section 5 -Page I/ page… | 2006 |
| * | K103007 | Affiniti Total and Hemi-Shoulder SystemSummary page 1…valent / Predicate device Aequalls Shoulder System, Tornia, K952928, K994392, K060209 and K063081 Affiniti Total and Hemi-Shoulder System, Tornier, Inc., K060988 and K103007 Section 5 -Page I/ page 4… | 2010 |
What descends from it? (49)
See all 493 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 3 of the 26 ancestors have a recall of any class.
- Of its descendants, K143374 (Tornier S.A.S., 2015) has gone furthest, with 31 descendants of its own.
- 18 other devices also cite its predicate K952928.
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. 2011, 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?
Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by:
- Degenerative pathologies: arthrosis, rheumatoid arthritis, post-traumatic arthrosis. Primary or secondary necrosis of the humeral head
- Displaced 4-part upper humeral fracture
- Hunieral head fracture
Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable.
Revision surgery when other treatments or devices have failed.
The Aequalis monobloc stein is cemented use.
The Aequalis Press-Fit is for uncemented use.
Glenoid component is for cemented use..
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111902 · printed Nov 5, 2026
Cite this page
510(k) Report. “K111902: Aequalis Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K111902
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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