CyclaPlex Implant

Basic Information

• Brand Name: CyclaPlex Implant
• Primary DI: 07290017626017
• Version / Model: V7
• Catalog Number: IM-9101
• Company Name: ALPHAMET LTD
• Labeler DUNS: 600372473
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-12
• Public Version: 3
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: 2bbf34b1-e907-4952-8890-d85c474e3746

Device Description

The implant is comprised of two metallic bone screws ("Anchor1", "Anchor 2") connected by an UHMW polyethylene multiple suture cord. The implant device pulls the 1st metatarsal inward, towards the 2nd metatarsal and reduces the intermetatarsal angle to normal medically-accepted values. It is intended to assist in the correction of Hallux Valgus deformities by providing reduction of the first intermetatarsal angle.

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: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• 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
HTN	Washer, Bolt Nut	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46646	Orthopaedic bone screw, non-bioabsorbable, sterile	A small, sterile, threaded 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 cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07290017626826	GS1	Shipping Box	3	In Commercial Distribution
Package	07290017626819	GS1	Packaging Box	20	In Commercial Distribution
Primary	07290017626017	GS1
Package	07290017626833	GS1	Shipping box	1	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K183094	000