FDA.reportPublic FDA data

Resurfacing humeral head prosthesis

Definition
A sterile implantable device designed to treat a disease-damaged (e.g., arthritic) shoulder joint by replacing the humeral articulating surface of the joint while preserving the natural humerus. It consists of a metallic humeral cap [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] that is placed over (resurfaces) a surgically-prepared humeral head, and may be used with a cementless stem.
GUDID devices
108
Last updated
2026-09-29 04:01:14

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00885556864029Titan Reverse Shoulder SystemSmith & Nephew, Inc.LNR-0960-00R2022-12-22
00885556864043Titan Reverse Shoulder SystemSmith & Nephew, Inc.LNR-0960-03R2022-12-22
00885556864067Titan Reverse Shoulder SystemSmith & Nephew, Inc.LNR-0960-06R2022-12-22
00885556864081Titan Reverse Shoulder SystemSmith & Nephew, Inc.LNR-0960-09R2022-12-22
08033390271356SMR SystemLIMACORPORATE SPA1327.10.4002024-02-22
08033390271387SMR SystemLIMACORPORATE SPA1327.10.4202024-02-22
08033390271394SMR SystemLIMACORPORATE SPA1327.10.4402024-02-22
08033390271400SMR SystemLIMACORPORATE SPA1327.10.4602024-02-22
08033390271417SMR SystemLIMACORPORATE SPA1327.10.4802024-02-22
08033390271424SMR SystemLIMACORPORATE SPA1327.10.5002024-02-22
08033390271431SMR SystemLIMACORPORATE SPA1327.10.5202024-02-22
08033390271448SMR SystemLIMACORPORATE SPA1327.10.5402024-02-22
08033390271790SMR SystemLIMACORPORATE SPA1328.10.4202024-02-22
08033390271806SMR SystemLIMACORPORATE SPA1328.10.4602024-02-22
08033390271820SMR SystemLIMACORPORATE SPA1328.10.5002024-02-22
08033390271851SMR SystemLIMACORPORATE SPA1328.10.5402024-02-22
10381780116219Titan™Ascension Orthopedics, Inc.HRA9005218WW2017-10-09
10381780121558Titan™ Reverse Shoulder SystemAscension Orthopedics, Inc.LNR096000R2017-10-09
10381780121565Titan™ Reverse Shoulder SystemAscension Orthopedics, Inc.LNR096003R2017-10-09
10381780121596Titan™ Reverse Shoulder SystemAscension Orthopedics, Inc.LNR096000S2017-10-09
10381780121602Titan™ Reverse Shoulder SystemAscension Orthopedics, Inc.LNR096003S2017-10-09
10885862248503EquinoxeExactech, Inc.312-01-382015-10-30
10885862248510EquinoxeExactech, Inc.312-01-412015-10-30
10885862248527EquinoxeExactech, Inc.312-01-442015-10-30
10885862248534EquinoxeExactech, Inc.312-01-472015-10-30
10885862248541EquinoxeExactech, Inc.312-01-502015-10-30
10885862248558EquinoxeExactech, Inc.312-01-532015-10-30
00885556837207Titan Humeral Resurfacing ArthroplastySmith & Nephew, Inc.HRA-900-40/16-WW2022-12-22
00885556837214Titan Humeral Resurfacing ArthroplastySmith & Nephew, Inc.HRA-900-44/15-WW2022-12-22
00885556837221Titan Humeral Resurfacing ArthroplastySmith & Nephew, Inc.HRA-900-44/18-WW2022-12-22
00885556837238Titan Humeral Resurfacing ArthroplastySmith & Nephew, Inc.HRA-900-48/17-WW2022-12-22
00885556837245Titan Humeral Resurfacing ArthroplastySmith & Nephew, Inc.HRA-900-48/20-WW2022-12-22
00885556837252Titan Humeral Resurfacing ArthroplastySmith & Nephew, Inc.HRA-900-52/18-WW2022-12-22
00885556837269Titan Humeral Resurfacing ArthroplastySmith & Nephew, Inc.HRA-900-52/21-WW2022-12-22
00885556837276Titan Humeral Resurfacing ArthroplastySmith & Nephew, Inc.HRA-900-56/21-WW2022-12-22
03700386926914AEQUALIS RESURFACING HEADTORNIERDWD8012015-10-16
03700386926921AEQUALIS RESURFACING HEADTORNIERDWD8022015-10-16
03700386926938AEQUALIS RESURFACING HEADTORNIERDWD8032015-10-16
03700386926945AEQUALIS RESURFACING HEADTORNIERDWD8042015-10-16
03700386926952AEQUALIS RESURFACING HEADTORNIERDWD8052015-10-16
03700386926969AEQUALIS RESURFACING HEADTORNIERDWD8062015-10-16
03700386926976AEQUALIS RESURFACING HEADTORNIERDWD8072015-10-16
03700386926983AEQUALIS RESURFACING HEADTORNIERDWD8082015-10-16
03700386926990AEQUALIS RESURFACING HEADTORNIERDWD8092015-10-16
03700386927003AEQUALIS RESURFACING HEADTORNIERDWD8102015-10-16
03700386927010AEQUALIS RESURFACING HEADTORNIERDWD8112015-10-16
03700386927027AEQUALIS RESURFACING HEADTORNIERDWD8122015-10-16
10603295018018GLOBAL CAP CTADEPUY ORTHOPAEDICS, INC.1235-40-0052015-09-24
10603295018025GLOBAL CAP CTADEPUY ORTHOPAEDICS, INC.1235-40-0152015-09-24
10603295018032GLOBAL CAP CTADEPUY ORTHOPAEDICS, INC.1235-44-0052015-09-24
10603295018049GLOBAL CAP CTADEPUY ORTHOPAEDICS, INC.1235-44-0152015-09-24
10603295018056GLOBAL CAP CTADEPUY ORTHOPAEDICS, INC.1235-48-0152015-09-24
10603295018063GLOBAL CAP CTADEPUY ORTHOPAEDICS, INC.1235-48-0252015-09-24
10603295018070GLOBAL CAP CTADEPUY ORTHOPAEDICS, INC.1235-52-0152015-09-24
10603295018087GLOBAL CAP CTADEPUY ORTHOPAEDICS, INC.1235-52-0252015-09-24
10603295018094GLOBAL CAP CTADEPUY ORTHOPAEDICS, INC.1235-56-0152015-09-24
10603295018100GLOBAL CAP CTADEPUY ORTHOPAEDICS, INC.1235-56-0252015-09-24
00810068850017Biocore9 Humeral Resurfacing SystemBiocore9, LLCHumeral Resurfacing Component 44 mm2021-09-28
00810068850024Biocore9 Humeral Resurfacing SystemBiocore9, LLCHumeral Resurfacing Component 48 mm2021-09-28
00810068850031Biocore9 Humeral Resurfacing SystemBiocore9, LLCHumeral Resurfacing Component 52 mm2021-09-28
00810068850048Biocore9 Humeral Resurfacing SystemBiocore9, LLCHumeral Resurfacing Component 56 mm2021-09-28
10381780116172Titan™Ascension Orthopedics, Inc.HRA9004415WW2017-10-09
10381780116165Titan™Ascension Orthopedics, Inc.HRA9004016WW2017-10-09
10381780116189Titan™Ascension Orthopedics, Inc.HRA9004418WW2017-10-09
10381780116196Titan™Ascension Orthopedics, Inc.HRA9004817WW2017-10-09
10381780116202Titan™Ascension Orthopedics, Inc.HRA9004820WW2017-10-09
10381780116226Titan™Ascension Orthopedics, Inc.HRA9005221WW2017-10-09
10381780116233Titan™Ascension Orthopedics, Inc.HRA9005621WW2017-10-09
M269HRA9005218WW1Titan™Ascension Orthopedics, Inc.HRA9005218WW2017-10-09
10381780121572Titan™ Reverse Shoulder SystemAscension Orthopedics, Inc.LNR096006R2017-10-09
10381780121589Titan™ Reverse Shoulder SystemAscension Orthopedics, Inc.LNR096009R2017-10-09
10381780121619Titan™ Reverse Shoulder SystemAscension Orthopedics, Inc.LNR096006S2017-10-09
10381780121626Titan™ Reverse Shoulder SystemAscension Orthopedics, Inc.LNR096009S2017-10-09
M269LNR096000R1Titan™ Reverse Shoulder SystemAscension Orthopedics, Inc.LNR096000R2017-10-09
M269LNR096000S1Titan™ Reverse Shoulder SystemAscension Orthopedics, Inc.LNR096000S2017-10-09
M269LNR096003R1Titan™ Reverse Shoulder SystemAscension Orthopedics, Inc.LNR096003R2017-10-09
M269LNR096003S1Titan™ Reverse Shoulder SystemAscension Orthopedics, Inc.LNR096003S2017-10-09
00811596030001CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.1228-7300-0022019-05-10
00811596030018CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.1228-7300-0012019-05-10
00811596030025CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.1228-7300-0032019-05-10