FDA.reportPublic FDA data

PRIMA TT Glenoid

Primary DI
08033390248563
Brand
PRIMA TT Glenoid
Company
LIMACORPORATE SPA
Model
1974.54.404
Catalog number
1974.54.404
Device description
PRIMA TT Glenoid - Glenosphere with Screw Dia. 40; Hign Lateralization (9mm)
Published
2026-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
PHXShoulder Prosthesis, Reverse Configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252352000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252352000SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.2026-01-22PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033390248563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033390248563080333902485638033390248563

GMDN Terms#

Term, Definition table
TermDefinition
Reverse shoulder prosthesis headA sterile component of a reverse shoulder prosthesis that consists of a hemisphere-shaped metal or combined metal/polyethylene piece (glenosphere) intended to be attached to the reverse shoulder base plate, or directly to the glenoid fossa of the scapula, to articulate with the reverse shoulder cup.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
432066322
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033390216036SMR Shoulder1379.5G.0301379.5G.0302026-05-11
08033390216043SMR Shoulder1379.5G.1201379.5G.1202026-05-11
08033390216050SMR Shoulder1379.5G.1241379.5G.1242026-05-11
08033390216067SMR Shoulder1379.5G.3201379.5G.3202026-05-11
08033390216074SMR Shoulder1379.5G.3221379.5G.3222026-05-11
08033390216081SMR Shoulder1379.5G.3241379.5G.3242026-05-11
08033390216098SMR Shoulder1379.5G.3301379.5G.3302026-05-11
08033390272797SMR System1375.15.6051375.15.6052026-02-25
08033390272803SMR System1375.15.6101375.15.6102026-02-25
08033390272810SMR System1375.15.6201375.15.6202026-02-25
08033390002233SMR System1362.09.0101362.09.0102026-02-19
08033390002240SMR System1362.09.0151362.09.0152026-02-19
08033390002257SMR System1362.09.0201362.09.0202026-02-19
08033390050029SMR System1362.09.1151362.09.1152026-02-19
08033390050036SMR System1362.09.1201362.09.1202026-02-19
08033390191135PRIMA1367.09.3761367.09.3762026-02-19
08033390201971PRIMA1367.09.2001367.09.2002026-02-19
08033390202299PRIMA1367.09.2031367.09.2032026-02-19
08033390202305PRIMA1367.09.2061367.09.2062026-02-19
08033390202312PRIMA1367.09.2701367.09.2702026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033390002233SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390002240SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390002257SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390050029SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390050036SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390115667SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390115698SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390115711SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390108065SMR STEMLESSLIMACORPORATE SPAPHX2022-03-17
07613327507096REUNIONStryker GmbHPHX2021-11-02
07613327354317REUNIONStryker GmbHPHX2021-04-27
07613327354348REUNIONStryker GmbHPHX2021-04-27
07613327354362REUNIONStryker GmbHPHX2021-04-27
07613327354393REUNIONStryker GmbHPHX2021-04-27
07613327354409REUNIONStryker GmbHPHX2021-04-27
07613327354782REUNIONStryker GmbHPHX2021-04-27
07613327354812REUNIONStryker GmbHPHX2021-04-27
07613327354829REUNIONStryker GmbHPHX2021-04-27
07613327354836REUNIONStryker GmbHPHX2021-04-27
07613327354881REUNIONStryker GmbHPHX2021-04-27
07613327354911REUNIONStryker GmbHPHX2021-04-27
07613327354928REUNIONStryker GmbHPHX2021-04-27
07613327354959REUNIONStryker GmbHPHX2021-04-27
07613327354966REUNIONStryker GmbHPHX2021-04-27
07613327354973REUNIONStryker GmbHPHX2021-04-27
07613327354997REUNIONStryker GmbHPHX2021-04-27
07613327355000REUNIONStryker GmbHPHX2021-04-27
07613327355017REUNIONStryker GmbHPHX2021-04-27
07613327355031REUNIONStryker GmbHPHX2021-04-27
07613327355048REUNIONStryker GmbHPHX2021-04-27