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AETOS Shoulder System

by Smith & Nephew, Inc. 2 variants

510(k) K220847

AETOS Shoulder System is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K220847 on 3 Jan 2023, 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 NumberK220847 Date3 Jan 2023ClearedStatusActive

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  • Withdrawn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

Cited by

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

Devices cleared under K220847

157 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 K220847
UDI-DISize and differences
AETOS Shoulder System GBP-0990-500-2
Smith & Nephew, Inc.
GBP-0990-500-2 / GBP-0990-500-200885556808436
Single use: yes
On the market
AETOS Shoulder System GBP-0990-501-2
Smith & Nephew, Inc.
GBP-0990-501-2 / GBP-0990-501-200885556808443
Single use: yes
On the market
AETOS Shoulder System GBP-0990-502-10F
Smith & Nephew, Inc.
GBP-0990-502-10F / GBP-0990-502-10F00885556814383
Single use: yes
On the market
AETOS Shoulder System GLN-0990-400-100
Smith & Nephew, Inc.
GLN-0990-400-100 / GLN-0990-400-10000885556816462
Single use: yes
On the market
AETOS Shoulder System GLN-0990-400-300
Smith & Nephew, Inc.
GLN-0990-400-300 / GLN-0990-400-30000885556816486
Single use: yes
On the market
AETOS Shoulder System GLN0990-403-005FR
Smith & Nephew, Inc.
GLN0990-403-005FR / GLN0990-403-005FR00885556815113
Single use: yes
On the market
AETOS Shoulder System GLN0990-403-010FR
Smith & Nephew, Inc.
GLN0990-403-010FR / GLN0990-403-010FR00885556816455
Single use: yes
On the market
AETOS Shoulder System GLN0990-403-105FL
Smith & Nephew, Inc.
GLN0990-403-105FL / GLN0990-403-105FL00885556816509
Single use: yes
On the market
AETOS Shoulder System GLN0990-403-210FR
Smith & Nephew, Inc.
GLN0990-403-210FR / GLN0990-403-210FR00885556816592
Single use: yes
On the market
AETOS Shoulder System GLN0990-403-305FL
Smith & Nephew, Inc.
GLN0990-403-305FL / GLN0990-403-305FL00885556816615
Single use: yes
On the market
AETOS Shoulder System GLN0990-403-310FL
Smith & Nephew, Inc.
GLN0990-403-310FL / GLN0990-403-310FL00885556816622
Single use: yes
On the market
AETOS Shoulder System GLN0990-403-310FR
Smith & Nephew, Inc.
GLN0990-403-310FR / GLN0990-403-310FR00885556816653
Single use: yes
On the market
AETOS Shoulder System GLS0990-506-3800E
Smith & Nephew, Inc.
GLS0990-506-3800E / GLS0990-506-3800E00885556814499
Single use: yes
On the market
AETOS Shoulder System GLS0990-506-4200E
Smith & Nephew, Inc.
GLS0990-506-4200E / GLS0990-506-4200E00885556814505
Single use: yes
On the market
AETOS Shoulder System HOS-0990-805-05
Smith & Nephew, Inc.
HOS-0990-805-05 / HOS-0990-805-0500885556811221
Single use: no
On the market
AETOS Shoulder System INS-0990-830-02
Smith & Nephew, Inc.
INS-0990-830-02 / INS-0990-830-0200885556811016
Single use: no
On the market
AETOS Shoulder System LNR-0990-200-380S
Smith & Nephew, Inc.
LNR-0990-200-380S / LNR-0990-200-380S00885556810170
Single use: yes
On the market
AETOS Shoulder System LNR-0990-200-420S
Smith & Nephew, Inc.
LNR-0990-200-420S / LNR-0990-200-420S00885556810071
Single use: yes
On the market
AETOS Shoulder System LNR-0990-202-343L
Smith & Nephew, Inc.
LNR-0990-202-343L / LNR-0990-202-343L00885556810729
Single use: yes
On the market
AETOS Shoulder System LNR-0990-202-346L
Smith & Nephew, Inc.
LNR-0990-202-346L / LNR-0990-202-346L00885556810736
Single use: yes
On the market
AETOS Shoulder System LNR-0990-202-349L
Smith & Nephew, Inc.
LNR-0990-202-349L / LNR-0990-202-349L00885556810743
Single use: yes
On the market
AETOS Shoulder System LNR-0990-202-386L
Smith & Nephew, Inc.
LNR-0990-202-386L / LNR-0990-202-386L00885556810774
Single use: yes
On the market
AETOS Shoulder System LNR-0990-202-389L
Smith & Nephew, Inc.
LNR-0990-202-389L / LNR-0990-202-389L00885556810781
Single use: yes
On the market
AETOS Shoulder System LNR-0990-202-426L
Smith & Nephew, Inc.
LNR-0990-202-426L / LNR-0990-202-426L00885556810811
Single use: yes
On the market
AETOS Shoulder System LNR0990-200-343SR
Smith & Nephew, Inc.
LNR0990-200-343SR / LNR0990-200-343SR00885556810200
Single use: yes
On the market
AETOS Shoulder System LNR0990-200-380SR
Smith & Nephew, Inc.
LNR0990-200-380SR / LNR0990-200-380SR00885556810132
Single use: yes
On the market
AETOS Shoulder System LNR0990-200-386SR
Smith & Nephew, Inc.
LNR0990-200-386SR / LNR0990-200-386SR00885556810057
Single use: yes
On the market
AETOS Shoulder System LNR0990-200-426SR
Smith & Nephew, Inc.
LNR0990-200-426SR / LNR0990-200-426SR00885556810668
Single use: yes
On the market
AETOS Shoulder System LNR0990-202-340LR
Smith & Nephew, Inc.
LNR0990-202-340LR / LNR0990-202-340LR00885556810835
Single use: yes
On the market
AETOS Shoulder System LNR0990-202-349LR
Smith & Nephew, Inc.
LNR0990-202-349LR / LNR0990-202-349LR00885556810866
Single use: yes
On the market
AETOS Shoulder System LNR0990-202-380LR
Smith & Nephew, Inc.
LNR0990-202-380LR / LNR0990-202-380LR00885556810873
Single use: yes
On the market
AETOS Shoulder System LNR0990-202-386LR
Smith & Nephew, Inc.
LNR0990-202-386LR / LNR0990-202-386LR00885556810897
Single use: yes
On the market
AETOS Shoulder System MHH-0990-102-4115
Smith & Nephew, Inc.
MHH-0990-102-4115 / MHH-0990-102-411500885556879832
Single use: yes
On the market
AETOS Shoulder System MHH-0990-102-5322
Smith & Nephew, Inc.
MHH-0990-102-5322 / MHH-0990-102-532200885556879917
Single use: yes
On the market
AETOS Shoulder System REM-0990-865-5
Smith & Nephew, Inc.
REM-0990-865-5 / REM-0990-865-500885556871430
Single use: no
On the market
AETOS Shoulder System SCW-0990-504-20
Smith & Nephew, Inc.
SCW-0990-504-20 / SCW-0990-504-2000885556813416
Length 20 mm
Single use: yes
On the market
AETOS Shoulder System SCW-0990-504-45
Smith & Nephew, Inc.
SCW-0990-504-45 / SCW-0990-504-4500885556813461
Length 45 mm
Single use: yes
On the market
AETOS Shoulder System SCW-0990-507-25
Smith & Nephew, Inc.
SCW-0990-507-25 / SCW-0990-507-2500885556813577
Length 25 mm
Single use: yes
On the market
AETOS Shoulder System SCW-0990-507-45
Smith & Nephew, Inc.
SCW-0990-507-45 / SCW-0990-507-4500885556813614
Length 45 mm
Single use: yes
On the market
AETOS Shoulder System STD-0990-837
Smith & Nephew, Inc.
STD-0990-837 / STD-0990-83700885556812723
Single use: no
On the market
AETOS Shoulder System STEM-0990-100-001
Smith & Nephew, Inc.
STEM-0990-100-001 / STEM-0990-100-00100885556814215
Single use: yes
On the market
AETOS Shoulder System STEM-0990-100-002
Smith & Nephew, Inc.
STEM-0990-100-002 / STEM-0990-100-00200885556814222
Single use: yes
On the market
AETOS Shoulder System SZR-0990-815-005
Smith & Nephew, Inc.
SZR-0990-815-005 / SZR-0990-815-00500885556812143
Single use: no
On the market
AETOS Shoulder System SZR-0990-815-010
Smith & Nephew, Inc.
SZR-0990-815-010 / SZR-0990-815-01000885556812150
Single use: no
On the market
AETOS Shoulder System SZR-0990-815-200
Smith & Nephew, Inc.
SZR-0990-815-200 / SZR-0990-815-20000885556812129
Single use: no
On the market
AETOS Shoulder System SZR-0990-815-205
Smith & Nephew, Inc.
SZR-0990-815-205 / SZR-0990-815-20500885556812181
Single use: no
On the market
AETOS Shoulder System SZR-0990-815-210
Smith & Nephew, Inc.
SZR-0990-815-210 / SZR-0990-815-21000885556812198
Single use: no
On the market
AETOS Shoulder System SZR-0990-815-305
Smith & Nephew, Inc.
SZR-0990-815-305 / SZR-0990-815-30500885556812204
Single use: no
On the market
AETOS Shoulder System SZR-0990-815-310
Smith & Nephew, Inc.
SZR-0990-815-310 / SZR-0990-815-31000885556812211
Single use: no
On the market
Trauma - Shoulders E0018145-8
Smith & Nephew, Inc.
E0018145-8 / E0018145-800885556912737
Single use: no
On the market

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