510(k) · Cleared
ClearedAequalis Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on Nov 9, 2006 as substantially equivalent to K952928 (Tornier, 1995) and 3 other predicates after a 30-day review. Its family tree reaches back 5 generations to 1993. 162 later devices descend from it.
- Decided
- Nov 9, 2006
- Review
- 30 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K920362 (1993). 21 ancestors in all, the oldest K873679 (1987). 162 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK920362 3M Modular Shoulder System3M Health Care, Ltd. · 1993
- 4 generations backK002683 WMT Ultra-Fit Modular Shoulder SystemWrightmedicaltechnologyinc · 2000
- 3 generations backK032679 Aequalis Shoulder Fracture SystemTornier · 2003
- 2 generations backK043077 Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder…Tornier · 2004
- 1 generation backK060209 Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier · 2006
- This deviceK063081 Aequalis Shoulder SystemTornier · 2006
- Descendant · cites it directly · 120 of its ownK071147 Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc. · 2007
- 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 · 2 generations on · 105 of its ownK113413 Ascend Shoulder SystemTornier, Inc. · 2012
- Descendant · 3 generations on · 98 of its ownK120794 Ascend Shoulder SystemTornier, Inc. · 2012
Showing 5 of 162 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 162 · See all- K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc. · 2007 · cites it directly120descendants
- K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011 · cites it directly110descendants
- K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 2 generations on108descendants
- K113413Ascend Shoulder SystemTornier, Inc. · 2012 · 2 generations on105descendants
- K120794Ascend Shoulder SystemTornier, Inc. · 2012 · 3 generations on98descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K920362 | 3M Modular Shoulder System | 3M Health Care, Ltd. | 1993 | — |
| −4 | K002683 | WMT Ultra-Fit Modular Shoulder System | Wrightmedicaltechnologyinc | 2000 | — |
| −3 | K032679 | Aequalis Shoulder Fracture System | Tornier | 2003 | — |
| −2 | K043077 | Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System | Tornier | 2004 | — |
| −1 | K060209 | Aequalis Shoulder Fracture System & Aequalis Shoulder System | Tornier | 2006 | — |
| 0 (this device) | K063081 | Aequalis Shoulder System | Tornier | 2006 | — |
| +1 | K071147 | Nexa Orthopedics Total Shoulder System | Nexa Orthopedics, Inc. | 2007 | — |
| +1 | K102924 | Aequalis Ascend Modular Anatomic Shoulder System | Tornier, Inc. | 2011 | — |
| +2 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| +2 | K113413 | Ascend Shoulder System | Tornier, Inc. | 2012 | — |
| +3 | K120794 | Ascend Shoulder System | Tornier, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 7 | 0 |
| 2017 | 6 | 0 |
| 2018 | 8 | 0 |
| 2019 | 12 | 0 |
| 2020 | 12 | 0 |
| 2021 | 13 | 0 |
| 2022 | 17 | 0 |
| 2023 | 14 | 0 |
| 2024 | 15 | 0 |
| 2025 | 18 | 0 |
| 2026 | 19 | 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 HSD? 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 HSD device
- #1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 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? (4)
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…Device class: Class II Classification panel: Orthopedic Product code: HSD 5) Equivalent / Predicate device Aequalis Shoulder System, Tomier, K952928, K043077, K060209 DePuy Global Shoulder System, DePuy Orthopaedics, Inc K060874 6) Device description The usual goal of total… | 1995 |
| * | K043077 | Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder SystemSummary page 1…ass: Class II Classification panel: Orthopedic Product code: HSD 5) Equivalent / Predicate device Aequalis Shoulder System, Tomier, K952928, K043077, K060209 DePuy Global Shoulder System, DePuy Orthopaedics, Inc K060874 6) Device description The usual goal of total shoulder… | 2004 |
| * | K060209 | Aequalis Shoulder Fracture System & Aequalis Shoulder SystemSummary page 1…Class II Classification panel: Orthopedic Product code: HSD 5) Equivalent / Predicate device Aequalis Shoulder System, Tomier, K952928, K043077, K060209 DePuy Global Shoulder System, DePuy Orthopaedics, Inc K060874 6) Device description The usual goal of total shoulder and hemi… | 2006 |
| * | K060874 | Depuy Global AP Shoulder SystemSummary page 1…code: HSD 5) Equivalent / Predicate device Aequalis Shoulder System, Tomier, K952928, K043077, K060209 DePuy Global Shoulder System, DePuy Orthopaedics, Inc K060874 6) Device description The usual goal of total shoulder and hemi-arthroplasty replacement of the shoulder is to restore the sh… | 2006 |
What descends from it? (162)
See all 1623 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 13 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 21 ancestors have a recall of any class.
- Of its descendants, K071147 (Nexa Orthopedics, Inc., 2007) has gone furthest, with 120 descendants of its own.
- 18 other devices also cite its predicate K952928.
How does its category compare?
All HSD devicesHSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HSD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HSD
145in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSD
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSD
757in 2025
MAUDE reports naming product code HSD, 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 | 4 | 72 | 0 | 128 |
| 2008 | 3 | 92 | 2 | 259 |
| 2009 | 0 | — | 2 | 156 |
| 2010 | 0 | — | 0 | 225 |
| 2011 | 2 | — | 0 | 241 |
| 2012 | 2 | — | 0 | 254 |
| 2013 | 4 | 218 | 0 | 288 |
| 2014 | 1 | — | 0 | 434 |
| 2015 | 0 | — | 0 | 574 |
| 2016 | 3 | 145 | 0 | 784 |
| 2017 | 0 | — | 3 | 985 |
| 2018 | 1 | — | 1 | 649 |
| 2019 | 0 | — | 0 | 830 |
| 2020 | 2 | — | 1 | 658 |
| 2021 | 0 | — | 0 | 573 |
| 2022 | 1 | — | 0 | 508 |
| 2023 | 0 | — | 0 | 586 |
| 2024 | 1 | — | 0 | 693 |
| 2025 | 0 | — | 0 | 757 |
| 2026 | 0 | — | 0 | — |
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 and secondary necrosis of the humeral head
- Displaced 4-part upper humeral fracture
- Humeral 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063081 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063081: 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/K063081
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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