FDA.reportPublic FDA data

Coated shoulder humeral stem prosthesis

Definition
A sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.
GUDID devices
1,202
Last updated
2026-07-17 21:59:04

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
03701037301074Humelock II Cementless Shoulder SystemFX SOLUTIONS311-02132016-06-09
03701037301098Humelock II Cementless Shoulder SystemFX SOLUTIONS311-02152016-06-09
03701037304570Humeris ShoulderFX SOLUTIONS316-00172017-12-14
03701037304594Humeris ShoulderFX SOLUTIONS316-00192017-12-14
03701037315132FX V 135 stemFX SOLUTIONS318-32102022-06-10
03701037315149FX V 135 stemFX SOLUTIONS318-32122022-06-10
03701037315156FX V 135 stemFX SOLUTIONS318-32142022-06-10
03701037315163FX V 135 stemFX SOLUTIONS318-32162022-06-10
03701037315187FX V 135 stemFX SOLUTIONS318-36122022-06-10
03701037315194FX V 135 stemFX SOLUTIONS318-36142022-06-10
03701037315200FX V 135 stemFX SOLUTIONS318-36162022-06-10
03701037315217FX V 135 stemFX SOLUTIONS318-36182022-06-10
03701037315224FX V 135 stemFX SOLUTIONS318-40122022-06-10
03701037315231FX V 135 stemFX SOLUTIONS318-40142022-06-10
03701037315248FX V 135 stemFX SOLUTIONS318-40162022-06-10
03701037315255FX V 135 stemFX SOLUTIONS318-40182022-06-10
03701037315262FX V 135 stemFX SOLUTIONS318-40202022-06-10
03701037315453FX V 135 humeral spacerFX SOLUTIONS203-00072022-06-10
03701037317884FX V 135 stemFX SOLUTIONS318-52082023-06-15
03701037317891FX V 135 stemFX SOLUTIONS318-52102023-06-15
03701037317907FX V 135 stemFX SOLUTIONS318-52122023-06-15
03701037317914FX V 135 stemFX SOLUTIONS318-54102023-06-15
03701037317921FX V 135 stemFX SOLUTIONS318-54122023-06-15
03701037317938FX V 135 stemFX SOLUTIONS318-54142023-06-15
03701037317945FX V 135 stemFX SOLUTIONS318-56122023-06-15
03701037317952FX V 135 stemFX SOLUTIONS318-56142023-06-15
03701037317969FX V 135 stemFX SOLUTIONS318-56162023-06-15
03701037318423FX V 135 stemFX SOLUTIONS318-18102023-06-15
03701037318430FX V 135 stemFX SOLUTIONS318-18112023-06-15
03701037318447FX V 135 stemFX SOLUTIONS318-18202023-06-15
03701037318454FX V 135 stemFX SOLUTIONS318-18212023-06-15
03701037318461FX V 135 stemFX SOLUTIONS318-18302023-06-15
03701037318478FX V 135 stemFX SOLUTIONS318-20102023-06-15
03701037318485FX V 135 stemFX SOLUTIONS318-20112023-06-15
03701037318492FX V 135 stemFX SOLUTIONS318-20202023-06-15
03701037318508FX V 135 stemFX SOLUTIONS318-20212023-06-15
03701037318515FX V 135 stemFX SOLUTIONS318-20302023-06-15
00840338603449Tornier HRS MaxTORNIER, INC.ARS10406092025-11-19
00840338603456Tornier HRS MaxTORNIER, INC.ARS10406102025-11-19
00840338603463Tornier HRS MaxTORNIER, INC.ARS10406112025-11-19
00840338603470Tornier HRS MaxTORNIER, INC.ARS10406122025-11-19
00840338603487Tornier HRS MaxTORNIER, INC.ARS10406132025-11-19
00840338603494Tornier HRS MaxTORNIER, INC.ARS10406142025-11-19
00840338603500Tornier HRS MaxTORNIER, INC.ARS10406152025-11-19
00840338603517Tornier HRS MaxTORNIER, INC.ARS10406162025-11-19
00840338603524Tornier HRS MaxTORNIER, INC.ARS10406172025-11-19
00840338603531Tornier HRS MaxTORNIER, INC.ARS10406182025-11-19
00840338603548Tornier HRS MaxTORNIER, INC.ARS10406192025-11-19
00840338603593Tornier HRS MaxTORNIER, INC.ARS104082025-11-19
00840338603609Tornier HRS MaxTORNIER, INC.ARS104092025-11-19
00840338603616Tornier HRS MaxTORNIER, INC.ARS104102025-11-19
00846832092215Tornier Perform Humeral SystemTORNIER, INC.PFX07090S2022-12-21
00846832092222Tornier Perform Humeral SystemTORNIER, INC.PFX07130S2022-12-22
00846832092239Tornier Perform Humeral SystemTORNIER, INC.PFX08130S2022-12-22
00846832092246Tornier Perform Humeral SystemTORNIER, INC.PFX08170S2022-12-22
00846832092253Tornier Perform Humeral SystemTORNIER, INC.PFX08210S2022-12-21
00846832092260Tornier Perform Humeral SystemTORNIER, INC.PFX09130S2022-12-21
00846832092277Tornier Perform Humeral SystemTORNIER, INC.PFX09170S2022-12-21
00846832092284Tornier Perform Humeral SystemTORNIER, INC.PFX09210S2022-12-21
00846832092291Tornier Perform Humeral SystemTORNIER, INC.PFX090902022-12-21
00846832092307Tornier Perform Humeral SystemTORNIER, INC.PFX091302022-12-21
00846832092314Tornier Perform Humeral SystemTORNIER, INC.PFX091702022-12-21
00846832092321Tornier Perform Humeral SystemTORNIER, INC.PFX092102022-12-21
00846832092338Tornier Perform Humeral SystemTORNIER, INC.PFX101302022-12-21
00846832092345Tornier Perform Humeral SystemTORNIER, INC.PFX101702022-12-21
00846832092352Tornier Perform Humeral SystemTORNIER, INC.PFX102102022-12-21
00846832092369Tornier Perform Humeral SystemTORNIER, INC.PFX111302022-12-21
00846832092376Tornier Perform Humeral SystemTORNIER, INC.PFX111702022-12-21
00846832092383Tornier Perform Humeral SystemTORNIER, INC.PFX112102022-12-21
00846832092390Tornier Perform Humeral SystemTORNIER, INC.PFX121302022-12-21
00846832092406Tornier Perform Humeral SystemTORNIER, INC.PFX121702022-12-21
00846832092413Tornier Perform Humeral SystemTORNIER, INC.PFX122102022-12-21
00846832092420Tornier Perform Humeral SystemTORNIER, INC.PFX131302022-12-21
00846832092437Tornier Perform Humeral SystemTORNIER, INC.PFX131702022-12-21
00846832092444Tornier Perform Humeral SystemTORNIER, INC.PFX132102022-12-21
00846832092451Tornier Perform Humeral SystemTORNIER, INC.PFX141302022-12-21
00846832092468Tornier Perform Humeral SystemTORNIER, INC.PFX141702022-12-21
00846832092475Tornier Perform Humeral SystemTORNIER, INC.PFX142102022-12-21
00846832092482Tornier Perform Humeral SystemTORNIER, INC.PFX151302022-12-21
00846832092499Tornier Perform Humeral SystemTORNIER, INC.PFX151702022-12-21