510(k) · Cleared
ClearedAequalis Shoulder Prosthesis
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 23, 1999 as substantially equivalent to K952928 (Tornier, 1995) and 2 other predicates after a 577-day review. Its family tree reaches back 1 generation to 1979. 160 later devices descend from it.
- Decided
- Aug 23, 1999
- Review
- 577 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K790987 (1979). 3 ancestors in all. 160 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK790987 Zimmer R Total Shoulder IIZimmer, Inc. · 1979
- This deviceK980244 Aequalis Shoulder ProsthesisTornier · 1999
- Descendant · cites it directly · 110 of its ownK102924 Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011
- Descendant · 2 generations on · 108 of its ownK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- Descendant · 3 generations on · 97 of its ownK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- Descendant · 4 generations on · 96 of its ownK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- Descendant · cites it directly · 71 of its ownK042021 Exactech Equinoxe Shoulder SystemExactech, Inc. · 2004 · Recalled
Showing 5 of 160 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 160 · See all- K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011 · cites it directly110descendants
- K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 2 generations on108descendants
- K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 3 generations on97descendants
- K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · 4 generations on96descendants
- K042021Exactech Equinoxe Shoulder SystemExactech, Inc. · 2004 · cites it directly71descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K790987 | Zimmer R Total Shoulder II | Zimmer, Inc. | 1979 | — |
| 0 (this device) | K980244 | Aequalis Shoulder Prosthesis | Tornier | 1999 | — |
| +1 | K102924 | Aequalis Ascend Modular Anatomic Shoulder System | Tornier, Inc. | 2011 | — |
| +2 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| +3 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| +4 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| +1 | K042021 | Exactech Equinoxe Shoulder System | Exactech, Inc. | 2004 | 10 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 6 | 0 |
| 2011 | 8 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 11 | 0 |
| 2019 | 11 | 0 |
| 2020 | 10 | 0 |
| 2021 | 11 | 0 |
| 2022 | 16 | 0 |
| 2023 | 11 | 0 |
| 2024 | 13 | 0 |
| 2025 | 14 | 0 |
| 2026 | 14 | 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? (3)
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 2…73 - fax 5. Special Controls: Special Controls do not apply to this device. 6. Substantially Equivalent Device(s): ZEqualis® Shoulder System (cemented), Tornier, S.A., K952928 Biomet Biomodular®, Biomet, Inc., K872454 -~ Neer lI®, Zimmer, Inc., K790987 7. Indications for use: Primary, secondary or post… | 1995 |
| * | K872454 | Biomet Modular Shoulder ProsthesisSummary page 2…trols do not apply to this device. 6. Substantially Equivalent Device(s): ZEqualis® Shoulder System (cemented), Tornier, S.A., K952928 Biomet Biomodular®, Biomet, Inc., K872454 -~ Neer lI®, Zimmer, Inc., K790987 7. Indications for use: Primary, secondary or post-traumatic osteoarthritis, rheumatoid arth… | 1987 |
| * | K790987 | Zimmer R Total Shoulder IISummary page 2…6. Substantially Equivalent Device(s): ZEqualis® Shoulder System (cemented), Tornier, S.A., K952928 Biomet Biomodular®, Biomet, Inc., K872454 -~ Neer lI®, Zimmer, Inc., K790987 7. Indications for use: Primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis, severe joint pain of osteoar… | 1979 |
What descends from it? (160)
See all 1603 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?
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?
Primary, secondary or post-traumatic osteoarthritis, rheumatoid arthritis, severe joint pain of osteoarticular origin compromising the patients quality of life, joints which are defective in shape and function, a revision intervention on a previous arthroplasty, and other disorders in which arthrodesis is not an acceptable option.
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/K980244 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980244: Aequalis Shoulder Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980244
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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