FDA.reportPublic FDA data

INHANCE

Primary DI
10603295546764
Brand
INHANCE
Company
DEPUY (IRELAND)
Model
5500-32-104
Catalog number
550032104
Device description
INHANCE SHOULDER SYSTEM REVERSE LINER RETENTIVE X-LINKED VITAMIN E PE Ø32+4mm
Published
2022-05-16
Public version status
New
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
10603295546764PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329554676410603295546764

GMDN Terms#

Term, Definition table
TermDefinition
Total reverse shoulder prosthesisA sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the joint particularly in patients with chronic, longstanding rotator cuff muscle tears, arthritis, and/or humeral fractures unsuccessfully treated by previous surgery. The device reverses normal anatomy so that the head portion of the joint is attached to the scapula and the socket portion is attached to the humerus. It typically includes a humeral stem and glenosphere (head) with body and cup components. The device may include screws for implantation and may be implanted with or without bone cement.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295033141S-ROM1365-16-5001365165002015-09-24
10603295033158S-ROM1365-17-5001365175002015-09-24
10603295033165S-ROM1365-18-5001365185002015-09-24
10603295033738S-ROM1365-41-5001365415002015-09-24
10603295033752S-ROM1365-42-5001365425002015-09-24
10603295033776S-ROM1365-43-5001365435002015-09-24
10603295033790S-ROM1365-44-5001365445002015-09-24
10603295033851S-ROM1365-45-5001365455002015-09-24
10603295033875S-ROM1365-47-5001365475002015-09-24
10603295034056S-ROM1365-61-5001365615002015-09-24
10603295034094S-ROM1365-62-5001365625002015-09-24
10603295034131S-ROM1365-63-5001365635002015-09-24
10603295034179S-ROM1365-64-5001365645002015-09-24
10603295034216S-ROM1365-65-5001365655002015-09-24
10603295034230S-ROM1365-66-5001365665002015-09-24
10603295170778S-ROM52-20225220222015-09-24
10603295079941AML EXCEL2001-42-0002001420002018-09-24
10603295080008AML EXCEL2001-47-0002001470002018-09-24
10603295080015AML EXCEL2001-48-0002001480002018-09-24
10603295080022AML EXCEL2001-49-0002001490002018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097513119Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00840097513126Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00840097513133Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00840097516004Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00840097516011Veritas Reverse Total ShoulderRestor3d, Inc.PHX2026-07-24
00811596031886Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031886Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031893Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031893Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031909Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031909Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031916Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031916Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031923Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031923Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031930Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031930Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031947Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031947Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031954Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031954Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031961CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-07-17
00811596031978CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-07-17
00811596031985CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-07-17
00811596031992EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031992EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031992EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-17
00811596032005Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596032005Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596032012Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17