Synicem Hip Spacer 48C demo

Basic Information

• Brand Name: Synicem Hip Spacer 48C demo
• Primary DI: 15060155712809
• Version / Model: 881502
• Catalog Number: 881502
• Company Name: BIOCOMPOSITES LTD
• Labeler DUNS: 424382307
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-08
• Public Version: 2
• Public Version Date: 2025-07-16
• Public Version Status: Update
• Public Device Record Key: 51637626-7219-4b6e-92b4-02adb2ce3d33

Device Description

DEMONSTRATIVE USE ONLY. NOT FOR USE IN PATIENTS OR FOR SALE Charnley Stem Type, 48mm Head, 130 mm Stem Length. Temporary implant which main function is to preserve the articular space during 2 Stage Revision Arthroplasty. Aids in treatment of infection that emerged due to the implant of hip replacement prosthesis. The hip spacer with gentamicin has a surgical steel core coated with radiopaque (barium sulfate) bone cement (PMMA) with antibiotic (gentamicin base). This is a long-term use implant, intended to be used for a maximum period of 180 days.

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1

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	15060155712809	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Charnley Stem Type, 48mm Head, 130 mm Stem Length.