FDA.reportPublic FDA data

INHANCE

Primary DI
10603295550396
Brand
INHANCE
Company
DEPUY (IRELAND)
Model
5505-05-290
Catalog number
550505290
Device description
INHANCE SHOULDER SYSTEM R/SPEED UNITI Baseplate LARGE Ø29mm CEMENTLESS
Published
2022-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
MBFPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
PAOprosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented
PHXshoulder prosthesis, reverse configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
PAOProsthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, CementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212737000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212737000INHANCE™ Reverse Shoulder SystemDepuy Ireland UC2022-04-21PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295550396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329555039610603295550396

GMDN Terms#

Term, Definition table
TermDefinition
Reverse shoulder prosthesis base plateA sterile component of a reverse shoulder prosthesis that consists of a metal plate [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] intended to be firmly attached to the scapula with screws. It is intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
989365556
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295168324SMARTSET3092-02030920202015-09-24
10603295168331SMARTSET3092-04030920402015-09-24
10603295168614NA3312-04033120402015-09-24
10603295168621NA3322-02033220202015-09-24
10603295168638NA3332-04033320402015-09-24
10603295005438GLOBAL AP1130-02-0001130020002015-09-24
10603295218289S-ROM87-34358734352015-09-24
10603295218470S-ROM87-35568735562015-09-24
10603295218487S-ROM87-35578735572015-09-24
10603295218951S-ROM87-59878759872015-09-24
10603295519935VELYS4515-70-2264515702262021-05-26
10603295519430VELYS4515-70-1024515701022021-05-13
10603295519492VELYS4515-70-1014515701012021-05-13
10603295519515VELYS4515-70-1004515701002021-05-13
10603295519379VELYS4515-70-1074515701072021-05-07
10603295519461VELYS4515-70-1054515701052021-05-07
10603295519478VELYS4515-70-1064515701062021-05-07
10603295519485VELYS4515-70-1094515701092021-05-07
10603295170655S-ROM52-15035215032015-09-24
10603295170662S-ROM52-15045215042015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00811596032579F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032586F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032593F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032609F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032616F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032623F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032630F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032647F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032654F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032661F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032678F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032685F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032982F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032036Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032050Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032067Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032074Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032081Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032098Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032104Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032111Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
05404028001028SurgiCase PlannerMaterialise NVPHX2025-08-28
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