510(k) · Cleared
ClearedAequalis PerFORM+ Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Jun 10, 2016 as substantially equivalent to K150583 (Tornier, Inc., 2015) after a 64-day review. Its family tree reaches back 11 generations to 1993. 7 later devices descend from it.
- Decided
- Jun 10, 2016
- Review
- 64 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K920362 (1993). 71 ancestors in all, the oldest K790987 (1979). 7 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK920362 3M Modular Shoulder System3M Health Care, Ltd. · 1993
- 7 generations between
- 3 generations backK111379 Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium…Exactech, Inc. · 2011 · Recalled
- 2 generations backK121220 Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small…Exactech, Inc. · 2012 · Recalled
- 1 generation backK150583 Aequalis PerFORM+ Shoulder SystemTornier, Inc. · 2015
- This deviceK160975 Aequalis PerFORM+ Shoulder SystemTornier, Inc. · 2016
- Descendant · cites it directly · 5 of its ownK220847 AETOS Shoulder SystemSmith & Nephew, Inc. · 2023
- Descendant · 2 generations on · 3 of its ownK240716 AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK230572 AETOS Shoulder SystemSmith & Nephew, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK260721 Tornier Perform Advanced GlenoidTornier, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK254084 AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026
Show all 11 generations
- Root · 11 generations backK920362 3M Modular Shoulder System3M Health Care, Ltd. · 1993
- 10 generations backK002683 WMT Ultra-Fit Modular Shoulder SystemWrightmedicaltechnologyinc · 2000
- 9 generations backK032679 Aequalis Shoulder Fracture SystemTornier · 2003
- 8 generations backK043077 Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder…Tornier · 2004
- 7 generations backK060209 Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier · 2006
- 6 generations backK081707 Aequalis Shoulder Fracture and Shoulder SystemsTornier, Inc. · 2008
- 5 generations backK093430 Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech…Exactech, Inc. · 2010 · Recalled
- 4 generations backK103419 Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc. · 2010 · Recalled
- 3 generations backK111379 Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium…Exactech, Inc. · 2011 · Recalled
- 2 generations backK121220 Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small…Exactech, Inc. · 2012 · Recalled
- 1 generation backK150583 Aequalis PerFORM+ Shoulder SystemTornier, Inc. · 2015
- This deviceK160975 Aequalis PerFORM+ Shoulder SystemTornier, Inc. · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K220847AETOS Shoulder SystemSmith & Nephew, Inc. · 2023 · cites it directly5descendants
- K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc. · 2024 · 2 generations on3descendants
- K230572AETOS Shoulder SystemSmith & Nephew, Inc. · 2023 · 2 generations on1descendant
- K260721Tornier Perform Advanced GlenoidTornier, Inc. · 2026 · cites it directly0descendants
- K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K920362 | 3M Modular Shoulder System | 3M Health Care, Ltd. | 1993 | — |
| −10 | K002683 | WMT Ultra-Fit Modular Shoulder System | Wrightmedicaltechnologyinc | 2000 | — |
| −9 | K032679 | Aequalis Shoulder Fracture System | Tornier | 2003 | — |
| −8 | K043077 | Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System | Tornier | 2004 | — |
| −7 | K060209 | Aequalis Shoulder Fracture System & Aequalis Shoulder System | Tornier | 2006 | — |
| −6 | K081707 | Aequalis Shoulder Fracture and Shoulder Systems | Tornier, Inc. | 2008 | — |
| −5 | K093430 | Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage… | Exactech, Inc. | 2010 | 1 |
| −4 | K103419 | Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TM | Exactech, Inc. | 2010 | 2 |
| −3 | K111379 | Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /… | Exactech, Inc. | 2011 | 2 |
| −2 | K121220 | Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/Right | Exactech, Inc. | 2012 | 2 |
| −1 | K150583 | Aequalis PerFORM+ Shoulder System | Tornier, Inc. | 2015 | — |
| 0 (this device) | K160975 | Aequalis PerFORM+ Shoulder System | Tornier, Inc. | 2016 | — |
| +1 | K220847 | AETOS Shoulder System | Smith & Nephew, Inc. | 2023 | — |
| +2 | K240716 | AETOS Shoulder System Stemless Humeral Prosthesis | Smith & Nephew, Inc. | 2024 | — |
| +2 | K230572 | AETOS Shoulder System | Smith & Nephew, Inc. | 2023 | — |
| +1 | K260721 | Tornier Perform Advanced Glenoid | Tornier, Inc. | 2026 | — |
| +2 | K254084 | AETOS Shoulder System - CONCELOC Glenoids | Smith & Nephew, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1987 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 8 | 0 |
| 2000 | 5 | 0 |
| 2001 | 7 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 6 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K150583 | Aequalis PerFORM+ Shoulder SystemSummary page 4…cemented prosthesis Regulatory Class: Class II Product Code: KWS III. Predicate Device Aequalis PerFORM+ Shoulder System, K150583 IV. Device Description The Aequalis PerFORM+ Shoulder System is a modular system consisting of a metaphyseal humeral stem c… | 2015 |
What descends from it? (7)
2 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 23 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 19 of the 71 ancestors have a recall of any class.
- Of its descendants, K220847 (Smith & Nephew, Inc., 2023) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K150583.
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. 2016, 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 (Aequalis PerFORM+ glenoid component and humeral component) may be indicated to relieve severe pain or significant disability caused by: • Degenerative pathologies: arthrosis, rheumatoid arthrosis, 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…
Read the full statement (102 words)
Prosthetic replacement with this device (Aequalis PerFORM+ glenoid component and humeral component) may be indicated to relieve severe pain or significant disability caused by:
• Degenerative pathologies: arthrosis, rheumatoid arthrosis, 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
The Aequalis PerFORM+ glenoids are intended for cemented use only.
The Aequalis monobloc stem is for cemented use
The Aequalis Press-Fit is for uncemented use
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160975 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160975: Aequalis PerFORM+ 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/K160975
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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