Biosteon® Cross Pin

Basic Information

• Brand Name: Biosteon® Cross Pin
• Primary DI: 15060155710362
• Version / Model: 234-500-350
• Catalog Number: 234-500-350
• Company Name: BIOCOMPOSITES LTD
• Labeler DUNS: 424382307
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-05-31
• Public Version: 4
• Public Version Date: 2024-01-03
• Public Version Status: Update
• Public Device Record Key: 16220e77-2913-40e3-8093-771f400199c9

Device Description

The Biosteon® Cross Pin is a bioabsorbable HA/PLLA, for surgical reconstruction of anterior cruciate ligament (ACL) deficient knee to provide cross pin femoral fixation of the various soft tissue ACL autografts and allografts.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• 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
HWC	Screw, Fixation, Bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45039	Bioabsorbable orthopaedic bone screw	A small, threaded, implantable rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). There are several kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded. A "lag screw" can be any of these used to obtain compression across bone fragments.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15060155710362	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	50	Millimeter
Width	6	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 39 – 117 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 4 – 47 Degrees Celsius