510(k) · Cleared
ClearedAETOS Shoulder System Meta Humeral Prosthesis Size 0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Oct 29, 2025 as substantially equivalent to K220847 (Smith & Nephew, Inc., 2023) and 2 other predicates after an 89-day review. Its family tree reaches back 19 generations to 1991. 1 of the 195 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 29, 2025
- Review
- 89 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 19 generations to K911686 (1991). 194 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 195 devices in this family, counting this one, has a Class I recall.
- Root · 19 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 15 generations between
- 3 generations backK190521 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2019
- 2 generations backK201315 PERFORM Humeral System – StemTornier, Inc. · 2020 · Recalled
- 1 generation backK230572 AETOS Shoulder SystemSmith & Nephew, Inc. · 2023
- This deviceK252416 AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc. · 2025
Show all 19 generations
- Root · 19 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 18 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 17 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 16 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 15 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 14 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 13 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 12 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 11 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 10 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 9 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 8 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 7 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 6 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 5 generations backK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
- 4 generations backK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
- 3 generations backK190521 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2019
- 2 generations backK201315 PERFORM Humeral System – StemTornier, Inc. · 2020 · Recalled
- 1 generation backK230572 AETOS Shoulder SystemSmith & Nephew, Inc. · 2023
- This deviceK252416 AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc. · 2025
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder4 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −18 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −17 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −16 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −15 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −14 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −13 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −12 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −11 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −10 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −9 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −8 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −7 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −6 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| −5 | K132285 | Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2013 | — |
| −4 | K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2015 | — |
| −3 | K190521 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2019 | — |
| −2 | K201315 | PERFORM Humeral System – Stem | Tornier, Inc. | 2020 | 1 |
| −1 | K230572 | AETOS Shoulder System | Smith & Nephew, Inc. | 2023 | — |
| 0 (this device) | K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0 | Smith & Nephew, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 5 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 3 | 0 |
| 1996 | 10 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 12 | 0 |
| 2001 | 10 | 0 |
| 2002 | 4 | 0 |
| 2003 | 7 | 0 |
| 2004 | 8 | 0 |
| 2005 | 8 | 0 |
| 2006 | 12 | 0 |
| 2007 | 7 | 0 |
| 2008 | 10 | 0 |
| 2009 | 3 | 0 |
| 2010 | 8 | 0 |
| 2011 | 11 | 0 |
| 2012 | 8 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K220847 | AETOS Shoulder SystemSummary page 6…metal/polymer non-constrained cemented prosthesis (21 CFR 888.3650) Classification Class II Predicate AETOS Shoulder System: K220847 (primary), K230572 Devices AETOS Shoulder System Stemless Humeral Prosthesis: K240716 Reference T… | 2023 |
| * | K230572 | AETOS Shoulder SystemSummary page 6…constrained cemented prosthesis (21 CFR 888.3650) Classification Class II Predicate AETOS Shoulder System: K220847 (primary), K230572 Devices AETOS Shoulder System Stemless Humeral Prosthesis: K240716 Reference Titan Reverse Should… | 2023 |
| * | K240716 | AETOS Shoulder System Stemless Humeral ProsthesisSummary page 6…ion Class II Predicate AETOS Shoulder System: K220847 (primary), K230572 Devices AETOS Shoulder System Stemless Humeral Prosthesis: K240716 Reference Titan Reverse Shoulder System: K130050, K173717 Devices Titan Modular Total Shoulder Sy… | 2024 |
| † | K130050 | Titan Reverse Shoulder System | 2013 |
| † | K173717 | Integra TITAN Reverse Shoulder System | 2018 |
| † | K100448 | Ascension Modular Total Shoulder System | 2010 |
| † | K142413 | TITAN Modular Total Shoulder System | 2014 |
| † | K122698 | Aequalis Ascend Flex Shoulder System | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 55 of the 194 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K220847.
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. 2025, 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?
In Anatomic: The AETOS Shoulder System (when used with the AETOS Humeral Meta Stems) is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The AETOS humeral stems (AETOS Humeral Meta Stems) and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid…
Read the full statement (420 words)
In Anatomic:
The AETOS Shoulder System (when used with the AETOS Humeral Meta Stems) is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.
The AETOS humeral stems (AETOS Humeral Meta Stems) and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.
When used with the AETOS Humeral Meta Stems, The AETOS Shoulder System is indicated for use as a replacement of shoulder joints disabled by:
• Rheumatoid arthritis
• Non-inflammatory degenerative joint disease
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of other devices if sufficient bone stock remains
The AETOS Shoulder System (when used with AETOS Stemless Humeral Prosthesis) is to be used only in patients with an intact or reconstructable rotator cuff.
When used with AETOS Stemless Humeral Prosthesis, the AETOS Shoulder System is indicated for anatomic total shoulder replacement of shoulder joints disabled by:
• Non-inflammatory degenerative joint disease
• Traumatic arthritis
• Revision of other devices if sufficient bone stock remains
The coated humeral components are intended for uncemented use. The glenoid component is intended for cemented use only.
In Reverse:
The AETOS Shoulder System, when used with AETOS Humeral Meta Stems, is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:
• Rheumatoid arthritis
• Non-inflammatory degenerative joint disease
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of devices if sufficient bone stock remains
The humeral liner component is indicated for use in the AETOS Shoulder System as a primary reverse total shoulder replacement and for use when converting an anatomic AETOS Shoulder System into a reverse shoulder construct. This facilitates the conversion without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The component is permitted to be used in the conversion from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthroplasty is associated with a massive and non-repairable rotator cuff tear.
The coated humeral stems are indicated for uncemented use. The coated glenoid base plate is intended for cementless application with the addition of screws for fixation.
Note: All implant components are single use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252416 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252416: AETOS Shoulder System Meta Humeral Prosthesis Size 0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252416
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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