FDA.reportPublic FDA data

Comprehensive Reverse Shoulder

Primary DI
00889024702134
Brand
Comprehensive Reverse Shoulder
Company
Zimmer, Inc.
Model
00-5380-040-01
Catalog number
00-5380-040-01
Published
2026-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

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
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
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253592000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253592000Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)Zimmer, Inc.2026-04-13MBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024702134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024702134008890247021348890247021340889024702134

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Height0

Regulatory Flags#

DUNS number
056038268
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024699939N/A1200020041200020042026-10-20
00889024699946N/A1200020051200020052026-10-20
00889024699953Alliance Glenoid, Identity Humeral1200060141200060142026-10-20
00889024709164CANNULATED 1.5MM HEX DRIVERSSI004137SSI0041372026-10-19
00889024709171CANNULATED 2.0MM HEX DRIVERSSI004138SSI0041382026-10-19
00889024715196T6 Driver 127mm AO QCSSI008712SSI0087122026-10-19
00889024715202T8 Driver 127mm AO QCSSI008713SSI0087132026-10-19
00889024715295Persona Extended V/V Guide Assembly (MFS)SSI008760SSI0087602026-10-19
00889024715271Affixus®2113060432113060432026-10-06
00889024707160G7® Vivacit-E®30104005301040052026-09-30
00889024707184G7® Vivacit-E®30103603301036032026-09-30
00889024707207G7® Vivacit-E®30104407301044072026-09-30
00889024711464Comp Mini Humeral Tray Trial Stem AdapterSSI008664SSI0086642026-08-25
008890247114712.9 JuggerKnot Self-Punching ObturatorSSI008672SSI0086722026-08-25
008890247114882.9 JuggerKnot Self-Punching CannulaSSI008671SSI0086712026-08-25
00889024712294Pin Target AssemblySSI001470SSI0014702026-08-25
00889024712300Z1 POSTERIOR HAMMR ADPTRSSI008666SSI0086662026-08-25
00889024712317Z1 ANTERIOR HAMMR ADPTRSSI008665SSI0086652026-08-25
00889024712843PTH SHELL PSTNR ASSYSSI008611SSI0086112026-08-25
00889024712850PTH SHELL ADPTR SMLLSSI008612SSI0086122026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097503677Veritas InstrumentationRestor3d, Inc.PHX2026-10-16
00889024707047Signature ONE Software PackageOrthosoft IncPHX2026-07-10
00889024707047Signature ONE Software PackageOrthosoft IncHSD2026-07-10
00889024707047Signature ONE Software PackageOrthosoft IncKWT2026-07-10
00889024707047Signature ONE Software PackageOrthosoft IncKWS2026-07-10
00889024707047Signature ONE Software PackageOrthosoft IncMBF2026-07-10
00887868554391Signature™ Comprehensive®Orthosoft IncKWT2024-02-09
00887868554391Signature™ Comprehensive®Orthosoft IncKWS2024-02-09
00887868554391Signature™ Comprehensive®Orthosoft IncMBF2024-02-09
00887868554391Signature™ Comprehensive®Orthosoft IncHSD2024-02-09
00887868554391Signature™ Comprehensive®Orthosoft IncPHX2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncMBF2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncHSD2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncKWT2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncKWS2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncPHX2024-02-09
00887868522987Signature ONEOrthosoft IncHSD2022-07-20
00887868522987Signature ONEOrthosoft IncPHX2022-07-20
00887868522987Signature ONEOrthosoft IncKWT2022-07-20
00887868522987Signature ONEOrthosoft IncKWS2022-07-20
00887868522987Signature ONEOrthosoft IncMBF2022-07-20
00887868522994Signature ONEOrthosoft IncKWS2022-07-20
00887868522994Signature ONEOrthosoft IncHSD2022-07-20
00887868522994Signature ONEOrthosoft IncMBF2022-07-20
00887868522994Signature ONEOrthosoft IncPHX2022-07-20
00887868522994Signature ONEOrthosoft IncKWT2022-07-20
00889024647046Signature ONE Software PackageOrthosoft IncMBF2022-07-05
00889024647046Signature ONE Software PackageOrthosoft IncHSD2022-07-05
00889024647046Signature ONE Software PackageOrthosoft IncPHX2022-07-05
00889024647046Signature ONE Software PackageOrthosoft IncKWT2022-07-05