CeMend Shoulder Spacer

Basic Information

• Brand Name: CeMend Shoulder Spacer
• Primary DI: 08058964729224
• Version / Model: AR-902-1042
• Company Name: G21 SRL
• Labeler DUNS: 431529195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-19
• Public Version: 1
• Public Version Date: 2025-12-29
• Public Version Status: New
• Public Device Record Key: 0611274b-89ae-4bfb-9006-9d965f9899ab

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MBB	Bone Cement, Antibiotic	Orthopedic	888.3027	2
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	888.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33982	Orthopaedic cement spacer	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08058964729224	GS1

Premarket Submissions

Submission Number	Supplement Number
K252443	000