FDA.reportPublic FDA data

CeMend Shoulder Spacer

Primary DI
08058964729248
Brand
CeMend Shoulder Spacer
Company
G21 SRL
Model
AR-902-1248
Device description
The CeMend Shoulder Spacer is a temporary shoulder spacer made with PMMA bone cement with Gentamicin and reinforced with a stainless steel core. The subject device is provided sterile, single use and is intended for temporary (maximum 180 days) use as part of a two-stage procedure in skeletally mature patients undergoing total or hemi shoulder arthroplasty revision due to prosthetic joint infection.
Published
2025-12-19
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
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
MBBBone Cement, Antibiotic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
MBBBone Cement, AntibioticOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252443000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252443000SpaceFix Shoulder SpacerG21, S.R.L.2025-09-15MBB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08058964729248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058964729248080589647292488058964729248

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement spacerA prefabricated device made of orthopaedic bone cement [e.g., polymethylmethacrylate (PMMA)], with an appropriate antibiotic, that is temporarily placed into a joint space to function as a carrier for the local delivery of antibiotic drugs and to prevent bone-on-bone contact and contraction of soft-tissue during surgical treatment of an infected joint. The shape and size of the device is modified to fit the joint space. This non-weight-bearing spacer remains in place until the infection clears; it is then removed and replaced with a conventional joint prosthesis. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
431529195
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08058964729163KeyFix_FILLER CANNULA FOR FENESTRATED SCREW 8-16 G9000302026-05-05
08058964729057Arthrex Bone Cement Closed Mixing Bowl AS-901-22024-10-14
08058964729064Arthrex Bone Cement Mixing Syringe AS-901-32024-10-14
08058964729071Arthrex Bone Cement Syringe Gun, DisposableAS-901-42024-10-14
08058964727862SpaceFlex Knee Trial9002012024-10-10
08058964728654Arthrex Bone Cement Mixing Syringe AR-901-32024-10-14
08058964728715Arthrex Bone Cement Open Mixing BowlAR-901-12024-10-14
08058964728753Arthrex Bone Cement Closed Mixing Bowl AR-901-22024-10-14
08058964728760Arthrex Bone Cement Syringe Gun, DisposableAR-901-42024-10-14
08058964729217CeMend Shoulder SpacerAR-902-08422025-12-19
08058964729224CeMend Shoulder SpacerAR-902-10422025-12-19
08058964729231CeMend Shoulder SpacerAR-902-10482025-12-19
08058964729255CeMend Shoulder Spacer Reamer TrayAR-902-C12025-12-19
08058964729262Reamer T-handleAR-902-132025-12-19
08058964729279CeMend Reamer 8mmAR-902-142025-12-19
08058964729286CeMend Reamer 10mmAR-902-152025-12-19
08058964729293CeMend Reamer 12mmAR-902-162025-12-19
08058964729309CeMend Reamer 14mmAR-902-172025-12-19
08058964729385CeMend Shoulder Spacer Trial 08 42AR-902-202025-12-19
08058964729392CeMend Shoulder Spacer Trial 10 42AR-902-212025-12-19

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