FDA.reportPublic FDA data

INHANCE

Primary DI
10603295546702
Brand
INHANCE
Company
DEPUY (IRELAND)
Model
5500-00-448
Catalog number
550000448
Device description
INHANCE SHOULDER SYSTEM REVERSE HUMERAL SHELL X-LARGE Ø44+8mm
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
10603295546702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329554670210603295546702

GMDN Terms#

Term, Definition table
TermDefinition
Reverse shoulder prosthesis bodyA sterile component of a reverse shoulder prosthesis that consists of a metallic piece [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)], which may be coated [e.g., with hydroxyapatite (HA)], intended to form a connection between a humeral stem prosthesis and a reverse shoulder prosthesis cup.

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
10603295079941AML EXCEL2001-42-0002001420002018-09-24
10603295080008AML EXCEL2001-47-0002001470002018-09-24
10603295080015AML EXCEL2001-48-0002001480002018-09-24
10603295080022AML EXCEL2001-49-0002001490002018-09-24
10603295080145NA2001-80-5012001805012018-09-24
10603295080770NA2002-25-0002002250002018-09-24
10603295080787NA2002-27-0002002270002018-09-24
10603295080794NA2002-31-0002002310002018-09-24
10603295082057TRI-LOCK2012-03-0052012030052018-09-24
10603295082064TRI-LOCK2012-03-0102012030102018-09-24
10603295082071TRI-LOCK2012-03-0202012030202018-09-24
10603295082088TRI-LOCK2012-03-0302012030302018-09-24
10603295082095TRI-LOCK2012-03-0402012030402018-09-24
10603295082101TRI-LOCK2012-03-0502012030502018-09-24
10603295082118TRI-LOCK2012-03-0602012030602018-09-24
10603295082125TRI-LOCK2012-03-0702012030702018-09-24
10603295082132TRI-LOCK2012-03-0802012030802018-09-24
10603295082149TRI-LOCK2012-03-0902012030902018-09-24
10603295082156TRI-LOCK2012-03-1002012031002018-09-24
10603295082163TRI-LOCK2012-03-1102012031102018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097535678Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535692Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535715Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535739Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535753Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535777Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535791Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535814Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535838Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535852Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535876Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535890Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097534978Veritas rTSARestor3d, Inc.PHX2026-06-02
00840097534985Veritas rTSARestor3d, Inc.PHX2026-06-02
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.HSD2026-05-28
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.KWS2026-05-28
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.KWT2026-05-28
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.MBF2026-05-28
07613327354331REUNIONStryker GmbHKWS2022-11-15
07613327354355REUNIONStryker GmbHKWS2022-11-15
07613327354379REUNIONStryker GmbHHSD2022-11-15
07613327354386REUNIONStryker GmbHHSD2022-11-15
07613327354799REUNIONStryker GmbHHSD2022-11-15
07613327354805REUNIONStryker GmbHKWS2022-11-15
07613327354843REUNIONStryker GmbHHSD2022-11-15
07613327354850REUNIONStryker GmbHHSD2022-11-15
07613327354867REUNIONStryker GmbHHSD2022-11-15
07613327354874REUNIONStryker GmbHHSD2022-11-15
07613327354898REUNIONStryker GmbHHSD2022-11-15
07613327354904REUNIONStryker GmbHKWS2022-11-15