510(k) Report

510(k) · Cleared

Cleared

AETOS Shoulder System

K220847510(k) TraditionalCleared Jan 3, 2023286-day reviewClass II21 CFR 888.3660

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Smith & Nephew, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Cleared on Jan 3, 2023 as substantially equivalent to K122698 (Tornier S.A.S., 2013) and 4 other predicates after a 286-day review. Its family tree reaches back 16 generations to 1991. 1 of the 177 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.

Decided
Jan 3, 2023
Review
286 days
Class
Class II
Product code
KWS
Recalls
None
Predicates
5

Its longest line of descent runs back 16 generations to K911686 (1991). 171 ancestors in all, the oldest K790987 (1979). 5 later devices descend from it, 4 citing it directly. 1 of the 177 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2016: 2 other ancestors2008: 9 other ancestors2015: 1 other ancestor2014: 3 other ancestors2012: 6 other ancestors2011: 6 other ancestors2010: 6 other ancestors2009: 3 other ancestors2007: 7 other ancestors2006: 12 other ancestors2005: 8 other ancestors2013: 2 other ancestors2004: 8 other ancestors2003: 7 other ancestors2001: 10 other ancestors1999: 6 other ancestors1995: 3 other ancestors2000: 11 other ancestors1998: 6 other ancestors1996: 9 other ancestors1980: 2 other ancestors2002: 4 other ancestors1997: 3 other ancestors1994: 6 other ancestors1992: 2 other ancestors1991: 3 other ancestors1987: 5 other ancestors1993: 1 other ancestor1988: 1 other ancestor1979: 1 other ancestor1989: 1 other ancestor1986: 1 other ancestor2025: 2 descendants cleared2023: 1 descendant cleared2026: 1 descendant cleared2024: 1 descendant clearedReference device: K152047 · INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid · Ascension Orthopedics · 2015Reference device: K063569 · Equinoxe Reverse Shoulder System · Exactech, Inc. · 2007 · recalledReference device: K181999 · Integra TITAN Reverse Shoulder System · Integra LifeSciences Corporation · 2018Reference device: K190588 · Integra TITAN Reverse Shoulder System · Integra LifeSciences Corporation · 2019Reference device: K142413 · TITAN Modular Total Shoulder System · Ascension Orthopedics · 2014Reference device: K100448 · Ascension Modular Total Shoulder System · Ascension Orthopedics, Inc. · 2010 · recalledReference device: K130050 · Titan Reverse Shoulder System · Ascension Orthopedic · 2013Reference device: K121543 · Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral Stems · Zimmer, Inc. · 2012Reference device: K181611 · Comprehensive Reverse Shoulder System · Biomet Manufacturing Corp · 2018K911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991×2: 2 generations cleared close together, K984541 (1999), K992065 (1999) ×3: 3 generations cleared close together, K021478 (2003), K030941 (2004), K041873 (2004) ×2: 2 generations cleared close together, K052906 (2005), K060704 (2006) K063569 · Equinoxe Reverse Shoulder System · Exactech, Inc. · 2007 · recalled×2: 2 generations cleared close together, K073688 (2008), K080642 (2008) ×2: 2 generations cleared close together, K110599 (2011), K112615 (2011) K122698 · Aequalis Ascend Flex Shoulder System · Tornier S.A.S. · 2013 · recalledK132285 · Aequalis Reversed Shoulder Prosthesis · Tornier S.A.S. · 2013K151293 · Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis · Tornier S.A.S. · 201519801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 15 other ancestors3 generations back: 21 other ancestors4 generations back: 35 other ancestors5 generations back: 25 other ancestors6 generations back: 24 other ancestors7 generations back: 19 other ancestors8 generations back: 12 other ancestors9 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 1 descendant K151293 · Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis · Tornier S.A.S. · 2015K132285 · Aequalis Reversed Shoulder Prosthesis · Tornier S.A.S. · 2013K122698 · Aequalis Ascend Flex Shoulder System · Tornier S.A.S. · 2013 · recalledK112615 · Aequalis Ascend Modular Reverse Shoulder System · Tornier, Inc. · 2011K110599 · Aequalis Ascend Modular Reverse Shoulder System · Tornier, Inc. · 2011K080642 · Comprehensive Reverse Shoulder · Biomet, Inc. · 2008 · Class I recallK073688 · Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw · Exactech, Inc. · 2008 · recalledK063569 · Equinoxe Reverse Shoulder System · Exactech, Inc. · 2007 · recalledK060704 · Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM · Zimmer, Inc. · 2006 · recalledK052906 · Zimmer Trabecular Metal Reverse Shoulder System · Zimmer, Inc. · 2005 · recalledK041873 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2004K030941 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2004K021478 · Delta Shoulder · Depuy, Inc. · 2003K992065 · Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head · DePuy Orthopaedics, Inc. · 1999K984541 · Global FX Humeral Stem, Global Advantage Humeral Head · DePuy Orthopaedics, Inc. · 1999K911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991−15−10−50
  1. Root · 16 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 12 generations between
  3. 3 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
  4. 2 generations backK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
  5. 1 generation backK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
  6. This deviceK220847 AETOS Shoulder SystemSmith & Nephew, Inc. · 2023
  7. Descendant · cites it directly · 3 of its ownK240716 AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc. · 2024
  8. Descendant · cites it directly · 1 of its ownK230572 AETOS Shoulder SystemSmith & Nephew, Inc. · 2023
  9. Descendant · cites it directly · 0 of its ownK254084 AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026
  10. Descendant · cites it directly · 0 of its ownK252416 AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc. · 2025
  11. Descendant · 2 generations on · 0 of its ownK252129 AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc. · 2025
Show all 16 generations
  1. Root · 16 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 15 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 14 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 13 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 12 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. 11 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. 10 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
  8. 9 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
  9. 8 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
  10. 7 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
  11. 6 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
  12. 5 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  13. 4 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  14. 3 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
  15. 2 generations backK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
  16. 1 generation backK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
  17. This deviceK220847 AETOS Shoulder SystemSmith & Nephew, Inc. · 2023

Class I recalls in this family

  • K080642 Comprehensive Reverse Shoulder4 generations back · 2008

Most influential descendants

Showing 5 of 5 · See all
  • K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc. · 2024 · cites it directly3descendants
  • K230572AETOS Shoulder SystemSmith & Nephew, Inc. · 2023 · cites it directly1descendant
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026 · cites it directly0descendants
  • K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc. · 2025 · cites it directly0descendants
  • K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−16K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−15K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−14K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−13K021478Delta ShoulderDepuy, Inc.2003—
−12K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
−11K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
−10K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200512
−9K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200610
−8K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200713
−7K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081
−6K080642Comprehensive Reverse ShoulderBiomet, Inc.2008Class I
−5K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
−4K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
−3K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.20132
−2K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.2013—
−1K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.2015—
0 (this device)K220847AETOS Shoulder SystemSmith & Nephew, Inc.2023—
+1K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.2024—
+1K230572AETOS Shoulder SystemSmith & Nephew, Inc.2023—
+1K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.2026—
+1K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.2025—
+2K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198020
198610
198750
198810
198910
199130
199220
199310
199460
199530
199690
199730
199860
199960
2000110
2001100
200240
200370
200480
200580
2006120
200770
200890
200930
201060
201160
201260
201320
201430
201510
201620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
202410
202520
202610
FIG. 1 — Lineage of K220847, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260721 Tornier Perform Advanced Glenoidscore 16.8 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K122698Aequalis Ascend Flex Shoulder System
Summary page 5
…semi-constrained cemented prosthesis (21 CFR 888.3660) Classification Class II Predicate Tornier SAS Aequalis Ascend Flex Shoulder System: K122698 (Primary), Device K151293 Tornier, Inc. Aequalis PerFORM Reversed, Aequalis PerFORM + Reversed…
Tornier S.A.S.20132
*K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis
Summary page 5
…(21 CFR 888.3660) Classification Class II Predicate Tornier SAS Aequalis Ascend Flex Shoulder System: K122698 (Primary), Device K151293 Tornier, Inc. Aequalis PerFORM Reversed, Aequalis PerFORM + Reversed Glenoid: K161742…
Tornier S.A.S.2015—
*K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid
Summary page 5
…ulder System: K122698 (Primary), Device K151293 Tornier, Inc. Aequalis PerFORM Reversed, Aequalis PerFORM + Reversed Glenoid: K161742 Tornier, Inc. Aequalis PerFORM + Shoulder System: K160975 PROMOS Reverse Shoulder System: K0810…
Tornier, Inc.20163
*K160975Aequalis PerFORM+ Shoulder System
Summary page 5
…Tornier, Inc. Aequalis PerFORM Reversed, Aequalis PerFORM + Reversed Glenoid: K161742 Tornier, Inc. Aequalis PerFORM + Shoulder System: K160975 PROMOS Reverse Shoulder System: K081016…
Tornier, Inc.2016—
*K081016Smith & Nephew, Inc., Promos Reverse Shoulder System
Summary page 5
…+ Reversed Glenoid: K161742 Tornier, Inc. Aequalis PerFORM + Shoulder System: K160975 PROMOS Reverse Shoulder System: K081016 K220847 - 2 of 4…
Smith & Nephew, Inc.20082
†K152047INTEGRA TITAN Modular Total Shoulder System Fin-Lock GlenoidAscension Orthopedics2015—
†K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200713
†K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation2018—
†K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation2019—
†K142413TITAN Modular Total Shoulder SystemAscension Orthopedics2014—
†K100448Ascension Modular Total Shoulder SystemAscension Orthopedics, Inc.20101
†K130050Titan Reverse Shoulder SystemAscension Orthopedic2013—
†K121543Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral StemsZimmer, Inc.2012—
†K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp2018—

Also cleared against K122698: 15 other devices →

What descends from it? (5)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243
K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231
K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260
K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250

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 32 years and passes through 9 companies; a new generation was cleared every 1.0 years on median.
  • 47 of the 171 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K240716 (Smith & Nephew, Inc., 2024) has gone furthest, with 3 descendants of its own.
  • 15 other devices also cite its predicate K122698.

How does its category compare?

All KWS devices

KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · KWS

3in 2025

2007: 22008: 42009: 42010: 72011: 112012: 72013: 122014: 72015: 82016: 102017: 72018: 42019: 92020: 32021: 52022: 52023: 42024: 22025: 32026 (partial year): 2
2007high 12 (2013) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWS

97in 2025

2008: 37 days median2009: 108 days median2010: 33 days median2011: 90 days median2012: 86 days median2013: 120 days median2014: 89 days median2015: 129 days median2016: 114 days median2017: 120 days median2018: 152 days median2019: 106 days median2020: 98 days median2021: 151 days median2022: 158 days median2023: 250 days median2025: 97 days median
2007high 250 (2023) · low 33 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWS

2in 2023

2007: 212008: 292010: 102011: 112012: 102014: 12016: 12017: 42018: 12019: 22020: 52023: 22026 (partial year): 1
2007high 29 (2008) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWS

2,281in 2025

2007: 1582008: 2382009: 2942010: 3932011: 4862012: 5422013: 8182014: 1,0662015: 1,1702016: 9702017: 1,6812018: 1,5452019: 1,7282020: 1,5672021: 1,3582022: 1,2682023: 1,7502024: 2,1222025: 2,281
2007high 2,281 (2025) · low 158 (2007)2025

MAUDE reports naming product code KWS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—21158
200843729238
200941080294
201073310393
2011119011486
201278610542
2013121200818
201478911,066
2015812901,170
2016101141970
2017712041,681
2018415211,545
2019910621,728
202039851,567
2021515101,358
2022515801,268
2023425021,750
20242—02,122
202539702,281
20262—1—

What is it indicated for?

In Anatomic: The stem 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. The AETOS Shoulder System 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 Shoulder System is indicated for use as a replacement…

Read the full statement (325 words)

In Anatomic:

The stem 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.

The AETOS Shoulder System 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 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 coated humeral component is intended for uncemented use. The glenoid component

is intended for cemented use only.

In Reverse:

The AETOS Shoulder System 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 stem is 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.

Also cleared against K122698

15 other devices cite the same predicate.

  • K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC · 2026
  • K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc. · 2025
  • K232226ARROW Off-Centred Humeral InsertFH Industrie · 2023
  • K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A. · 20222 recalls
  • K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
  • K191963SMR Finned Short StemsLima Corporate S.P.A. · 2019

More from Smith & Nephew, Inc.

692 FDA decisions under this applicant name. See the company

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)…Smith & Nephew, Inc. · 2026
  • DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026

Recent decisions in KWS

The KWS category page

  • K260721Tornier Perform Advanced GlenoidTornier, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026
  • K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc. · 2025
  • K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc. · 2025
  • K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A. · 2025

https://510kreport.com/device/K220847 · printed Nov 5, 2026

Cite this page

510(k) Report. “K220847: AETOS 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/K220847

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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