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AETOS Shoulder System - CONCELOC Glenoids

by Smith & Nephew, Inc.

510(k) K254084

AETOS Shoulder System - CONCELOC Glenoids is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K254084 on 6 Apr 2026, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK254084 Date6 Apr 2026ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
KWS
Device class
Class II
Regulation
21 CFR Part 888.3660
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K254084

40 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K254084
UDI-DISize and differences
AETOS Shoulder System DRG-0990-852-05FML
Smith & Nephew, Inc.
DRG-0990-852-05FML / DRG-0990-852-05FML00885556916858
Single use: no
On the market
AETOS Shoulder System DRG-0990-852-05FMR
Smith & Nephew, Inc.
DRG-0990-852-05FMR / DRG-0990-852-05FMR00885556916872
Single use: no
On the market
AETOS Shoulder System DRG-0990-852-05FXL
Smith & Nephew, Inc.
DRG-0990-852-05FXL / DRG-0990-852-05FXL00885556916841
Single use: no
On the market
AETOS Shoulder System DRG-0990-852-05FXR
Smith & Nephew, Inc.
DRG-0990-852-05FXR / DRG-0990-852-05FXR00885556916865
Single use: no
On the market
AETOS Shoulder System DRG-0990-852-10FML
Smith & Nephew, Inc.
DRG-0990-852-10FML / DRG-0990-852-10FML00885556916896
Single use: no
On the market
AETOS Shoulder System DRG-0990-852-10FMR
Smith & Nephew, Inc.
DRG-0990-852-10FMR / DRG-0990-852-10FMR00885556916919
Single use: no
On the market
AETOS Shoulder System DRG-0990-852-10FXL
Smith & Nephew, Inc.
DRG-0990-852-10FXL / DRG-0990-852-10FXL00885556916889
Single use: no
On the market
AETOS Shoulder System DRG-0990-852-10FXR
Smith & Nephew, Inc.
DRG-0990-852-10FXR / DRG-0990-852-10FXR00885556916902
Single use: no
On the market
AETOS Shoulder System DRG-0990-852-ML
Smith & Nephew, Inc.
DRG-0990-852-ML / DRG-0990-852-ML00885556916971
Single use: no
On the market
AETOS Shoulder System DRG-0990-852-XS
Smith & Nephew, Inc.
DRG-0990-852-XS / DRG-0990-852-XS00885556916964
Single use: no
On the market
AETOS Shoulder System EDG-0990-092-DE
Smith & Nephew, Inc.
EDG-0990-092-DE / EDG-0990-092-DE00885556917213
Single use: no
On the market
AETOS Shoulder System EDG-0990-092-ET
Smith & Nephew, Inc.
EDG-0990-092-ET / EDG-0990-092-ET00885556917220
Single use: yes
On the market
AETOS Shoulder System EDG-0990-092-PT
Smith & Nephew, Inc.
EDG-0990-092-PT / EDG-0990-092-PT00885556924426
Single use: yes
On the market
AETOS Shoulder System EDG-0990-092-XS
Smith & Nephew, Inc.
EDG-0990-092-XS / EDG-0990-092-XS00885556917183
Single use: no
On the market
AETOS Shoulder System EDG-0990-369-LG
Smith & Nephew, Inc.
EDG-0990-369-LG / EDG-0990-369-LG00885556917206
Single use: no
On the market
AETOS Shoulder System EDG-0990-369-MG
Smith & Nephew, Inc.
EDG-0990-369-MG / EDG-0990-369-MG00885556917190
Single use: no
On the market
AETOS Shoulder System EDG-0990-369-SD
Smith & Nephew, Inc.
EDG-0990-369-SD / EDG-0990-369-SD00885556917695
Single use: no
On the market
AETOS Shoulder System HGD-0990-092-HDP
Smith & Nephew, Inc.
HGD-0990-092-HDP / HGD-0990-092-HDP00885556917107
Single use: no
On the market
AETOS Shoulder System HGD-0990-092-HFC
Smith & Nephew, Inc.
HGD-0990-092-HFC / HGD-0990-092-HFC00885556917121
Single use: no
On the market
AETOS Shoulder System HGD-0990-092-HPC
Smith & Nephew, Inc.
HGD-0990-092-HPC / HGD-0990-092-HPC00885556917114
Single use: no
On the market
AETOS Shoulder System HGL-0990-301-000
Smith & Nephew, Inc.
HGL-0990-301-000 / HGL-0990-301-00000885556916360
Single use: yes
On the market
AETOS Shoulder System HGL-0990-301-100
Smith & Nephew, Inc.
HGL-0990-301-100 / HGL-0990-301-10000885556916339
Single use: yes
On the market
AETOS Shoulder System HGL-0990-301-200
Smith & Nephew, Inc.
HGL-0990-301-200 / HGL-0990-301-20000885556916346
Single use: yes
On the market
AETOS Shoulder System HGL-0990-301-300
Smith & Nephew, Inc.
HGL-0990-301-300 / HGL-0990-301-30000885556916353
Single use: yes
On the market
AETOS Shoulder System HGL-0990-303-005FL
Smith & Nephew, Inc.
HGL-0990-303-005FL / HGL-0990-303-005FL00885556915943
Single use: yes
On the market
AETOS Shoulder System HGL-0990-303-005FR
Smith & Nephew, Inc.
HGL-0990-303-005FR / HGL-0990-303-005FR00885556916063
Single use: yes
On the market
AETOS Shoulder System HGL-0990-303-010FL
Smith & Nephew, Inc.
HGL-0990-303-010FL / HGL-0990-303-010FL00885556915981
Single use: yes
On the market
AETOS Shoulder System HGL-0990-303-010FR
Smith & Nephew, Inc.
HGL-0990-303-010FR / HGL-0990-303-010FR00885556916100
Single use: yes
On the market
AETOS Shoulder System HGL-0990-303-105FL
Smith & Nephew, Inc.
HGL-0990-303-105FL / HGL-0990-303-105FL00885556915950
Single use: yes
On the market
AETOS Shoulder System HGL-0990-303-105FR
Smith & Nephew, Inc.
HGL-0990-303-105FR / HGL-0990-303-105FR00885556916070
Single use: yes
On the market
AETOS Shoulder System HGL-0990-303-110FL
Smith & Nephew, Inc.
HGL-0990-303-110FL / HGL-0990-303-110FL00885556915998
Single use: yes
On the market
AETOS Shoulder System HGL-0990-303-110FR
Smith & Nephew, Inc.
HGL-0990-303-110FR / HGL-0990-303-110FR00885556916117
Single use: yes
On the market
AETOS Shoulder System HGL-0990-303-205FL
Smith & Nephew, Inc.
HGL-0990-303-205FL / HGL-0990-303-205FL00885556915967
Single use: yes
On the market
AETOS Shoulder System HGL-0990-303-205FR
Smith & Nephew, Inc.
HGL-0990-303-205FR / HGL-0990-303-205FR00885556916087
Single use: yes
On the market
AETOS Shoulder System HGL-0990-303-210FL
Smith & Nephew, Inc.
HGL-0990-303-210FL / HGL-0990-303-210FL00885556916001
Single use: yes
On the market
AETOS Shoulder System HGL-0990-303-210FR
Smith & Nephew, Inc.
HGL-0990-303-210FR / HGL-0990-303-210FR00885556916124
Single use: yes
On the market
AETOS Shoulder System HGL-0990-303-305FL
Smith & Nephew, Inc.
HGL-0990-303-305FL / HGL-0990-303-305FL00885556915974
Single use: yes
On the market
AETOS Shoulder System HGL-0990-303-305FR
Smith & Nephew, Inc.
HGL-0990-303-305FR / HGL-0990-303-305FR00885556916094
Single use: yes
On the market
AETOS Shoulder System HGL-0990-303-310FL
Smith & Nephew, Inc.
HGL-0990-303-310FL / HGL-0990-303-310FL00885556916018
Single use: yes
On the market
AETOS Shoulder System HGL-0990-303-310FR
Smith & Nephew, Inc.
HGL-0990-303-310FR / HGL-0990-303-310FR00885556916131
Single use: yes
On the market

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