Synicem 48M Hip Trial FDA

Basic Information

• Brand Name: Synicem 48M Hip Trial FDA
• Primary DI: 15060155712267
• Version / Model: 885412
• Catalog Number: 885412
• 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: 1
• Public Version Date: 2025-07-16
• Public Version Status: New
• Public Device Record Key: 90ae2c5e-77ac-4abd-8f98-81c98713c4a0

Device Description

Reusable Hip Trial Spacer allows for the selection of the correct hip spacer to avoid manipulation prior to implantation during a 2-step revision hip arthroplasty. Reproduce the shape & size of the corresponding spacers. Provided non-sterile. Medical or surgical support personnel using the “Trial Spacer” should familiarize themselves with the product within the context of their duties & responsibilities prior to use. These accessories are for momentary use.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
63525	Hip revision prosthesis trial	A copy of a final hip revision prosthesis, in the form of a combined femoral stem and head, designed to be used before revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is one of a set, or a set, of graduated sizes and is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15060155712267	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Muller Stem Type, 48mm Head, 120 mm Stem Length