Synicem Hip Spacer 48M 885436

GUDID 15060155712083

Muller Stem Type, 48mm Head, 120 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.

BIOCOMPOSITES LTD

Orthopaedic cement spacer

• Primary Device ID: 15060155712083
• NIH Device Record Key: 9ebf0473-54da-46f8-a2e6-4c1afaa14a66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synicem Hip Spacer 48M
• Version Model Number: 885436
• Catalog Number: 885436
• Company DUNS: 424382307
• Company Name: BIOCOMPOSITES LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	15060155712083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242865

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-16
• Device Publish Date: 2025-07-08

Devices Manufactured by BIOCOMPOSITES LTD

• 15060155712021 - Synicem Hip Spacer 40C: 2025-07-16 Synicem 40C Hip Spacer. Charnley Stem Type, 40mm Head, 127 mm Stem Length. Temporary implant which main function is to preserve
• 15060155712038 - Synicem Hip Spacer 48C: 2025-07-16 Charnley Stem Type, 48mm Head, 130 mm Stem Length. Temporary implant which main function is to preserve the articular space duri
• 15060155712045 - Synicem Hip Spacer 56C: 2025-07-16 Charnley Stem Type, 56mm Head, 130 mm Stem Length. Temporary implant which main function is to preserve the articular space duri
• 15060155712052 - Synicem Hip Spacer 40CXL: 2025-07-16 Charnley Stem Type, 40mm Head, 250 mm Stem Length. Temporary implant which main function is to preserve the articular space duri
• 15060155712069 - Synicem Hip Spacer 48CXL: 2025-07-16 Charnley Stem Type, 48mm Head, 250mm Stem Length Temporary implant which main function is to preserve the articular space durin
• 15060155712076 - Synicem Hip Spacer 56CXL: 2025-07-16 Charnley Stem Type, 56mm Head, 250 mm Stem Length. Temporary implant which main function is to preserve the articular space duri
• 15060155712083 - Synicem Hip Spacer 48M: 2025-07-16Muller Stem Type, 48mm Head, 120 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.
• 15060155712083 - Synicem Hip Spacer 48M: 2025-07-16 Muller Stem Type, 48mm Head, 120 mm Stem Length. Temporary implant which main function is to preserve the articular space during
• 15060155712090 - Synicem Hip Spacer 56M: 2025-07-16 Muller Stem Type, 56mm Head, 127mm Stem Length. Temporary implant which main function is to preserve the articular space during