510(k) Report

510(k) · Cleared

Cleared

AETOS Shoulder System - CONCELOC Glenoids

K254084510(k) TraditionalCleared Apr 6, 2026109-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 Apr 6, 2026 as substantially equivalent to K240716 (Smith & Nephew, Inc., 2024) and 4 other predicates after a 109-day review. Its family tree reaches back 18 generations to 1991. 1 of the 215 devices in its family, counting itself, has a Class I recall.

Decided
Apr 6, 2026
Review
109 days
Class
Class II
Product code
KWS
Recalls
None
Predicates
5

Its longest line of descent runs back 18 generations to K911686 (1991). 214 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 215 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2022: 1 other ancestor2021: 1 other ancestor2014: 4 other ancestors2016: 2 other ancestors2015: 2 other ancestors2013: 4 other ancestors2012: 7 other ancestors2011: 7 other ancestors2010: 8 other ancestors2008: 9 other ancestors2005: 13 other ancestors1996: 13 other ancestors1995: 6 other ancestors2009: 3 other ancestors2007: 8 other ancestors2006: 14 other ancestors2004: 9 other ancestors2003: 14 other ancestors1999: 7 other ancestors2002: 6 other ancestors2001: 10 other ancestors2000: 12 other ancestors1998: 7 other ancestors1997: 4 other ancestors1989: 2 other ancestors1986: 2 other ancestors1994: 6 other ancestors1992: 2 other ancestors1991: 3 other ancestors1987: 5 other ancestors1980: 2 other ancestors1979: 1 other ancestor1993: 1 other ancestor1988: 1 other ancestorK911686 · 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. · 2015K220847 · AETOS Shoulder System · Smith & Nephew, Inc. · 2023K240716 · AETOS Shoulder System Stemless Humeral Prosthesis · Smith & Nephew, Inc. · 202419801990200020102020
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 13 other ancestors3 generations back: 30 other ancestors4 generations back: 51 other ancestors5 generations back: 39 other ancestors6 generations back: 21 other ancestors7 generations back: 20 other ancestors8 generations back: 11 other ancestors9 generations back: 7 other ancestors10 generations back: 1 other ancestor K240716 · AETOS Shoulder System Stemless Humeral Prosthesis · Smith & Nephew, Inc. · 2024K220847 · AETOS Shoulder System · Smith & Nephew, Inc. · 2023K151293 · 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 · 18 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 14 generations between
  3. 3 generations backK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
  4. 2 generations backK220847 AETOS Shoulder SystemSmith & Nephew, Inc. · 2023
  5. 1 generation backK240716 AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc. · 2024
  6. This deviceK254084 AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026
Show all 18 generations
  1. Root · 18 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 17 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 16 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 15 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 14 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. 13 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. 12 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
  8. 11 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
  9. 10 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
  10. 9 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
  11. 8 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
  12. 7 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  13. 6 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  14. 5 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
  15. 4 generations backK132285 Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2013
  16. 3 generations backK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
  17. 2 generations backK220847 AETOS Shoulder SystemSmith & Nephew, Inc. · 2023
  18. 1 generation backK240716 AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc. · 2024
  19. This deviceK254084 AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026

Class I recalls in this family

  • K080642 Comprehensive Reverse Shoulder5 generations back · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−18K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−17K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−16K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−15K021478Delta ShoulderDepuy, Inc.2003—
−14K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
−13K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
−12K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200512
−11K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200610
−10K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200713
−9K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081
−8K080642Comprehensive Reverse ShoulderBiomet, Inc.2008Class I
−7K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
−6K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
−5K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.20132
−4K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.2013—
−3K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.2015—
−2K220847AETOS Shoulder SystemSmith & Nephew, Inc.2023—
−1K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.2024—
0 (this device)K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198020
198620
198750
198810
198920
199130
199220
199310
199460
199560
1996130
199740
199870
199970
2000120
2001100
200260
2003140
200490
2005130
2006140
200780
200890
200930
201080
201170
201270
201340
201440
201520
201620
202110
202210
FIG. 1 — Lineage of K254084, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 K220847 AETOS Shoulder Systemscore 21.1 · 16 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
*K240716AETOS Shoulder System Stemless Humeral Prosthesis
Summary page 6
…joint metal/polymer non-constrained cemented prosthesis (21 CFR 888.3650) Classification Class II Predicate AETOS Shoulder System: K240716 (Primary), K220847 Devices Exactech Equinoxe Laser Cage Glenoid: K212356 Titan Modular Shou…
Smith & Nephew, Inc.2024—
*K220847AETOS Shoulder System
Summary page 6
…r non-constrained cemented prosthesis (21 CFR 888.3650) Classification Class II Predicate AETOS Shoulder System: K240716 (Primary), K220847 Devices Exactech Equinoxe Laser Cage Glenoid: K212356 Titan Modular Shoulder System: K14241…
Smith & Nephew, Inc.2023—
*K212356Exactech® Equinoxe® Laser Cage Glenoid
Summary page 6
…8.3650) Classification Class II Predicate AETOS Shoulder System: K240716 (Primary), K220847 Devices Exactech Equinoxe Laser Cage Glenoid: K212356 Titan Modular Shoulder System: K142413 Porous Patella and Porous Tibia Baseplate: K211221 C…
Exactech, Inc.20221
*K142413TITAN Modular Total Shoulder System
Summary page 6
…OS Shoulder System: K240716 (Primary), K220847 Devices Exactech Equinoxe Laser Cage Glenoid: K212356 Titan Modular Shoulder System: K142413 Porous Patella and Porous Tibia Baseplate: K211221 Classification Orthopedic Panel Device…
Ascension Orthopedics2014—
*K211221Porous Patella and Porous Tibia Baseplate
Summary page 6
…Exactech Equinoxe Laser Cage Glenoid: K212356 Titan Modular Shoulder System: K142413 Porous Patella and Porous Tibia Baseplate: K211221 Classification Orthopedic Panel Device The AETOS CONCELOC Glenoids subject to this submission are…
Smith & Nephew, Inc.2021—

Also cleared against K240716: 2 other devices →

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 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 35 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
  • 70 of the 214 ancestors have a recall of any class; 1 has a Class I recall.
  • 2 other devices also cite its predicate K240716.

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. 2026, 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 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.

Also cleared against K240716

2 other devices cite the same predicate.

  • K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc. · 2025
  • K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc. · 2025

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
  • P000057/S013Ascension MCPSmith & Nephew, Inc. · 2025

Recent decisions in KWS

The KWS category page

  • K260721Tornier Perform Advanced GlenoidTornier, 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
  • K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, Inc.) · 2024

https://510kreport.com/device/K254084 · printed Nov 4, 2026

Cite this page

510(k) Report. “K254084: AETOS Shoulder System - CONCELOC Glenoids.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254084

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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