Accu-Joint

Basic Information

• Brand Name: Accu-Joint
• Primary DI: 00850044114191
• Version / Model: AJPI-15-15
• Catalog Number: AJPI-15-15
• Company Name: Accufix Surgical, Inc.
• Labeler DUNS: 045694474
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-28
• Public Version: 1
• Public Version Date: 2022-11-07
• Public Version Status: New
• Public Device Record Key: e056e03e-a85b-439a-b5fd-26cb43985da5

Device Description

Accu-Joint Hemi Implant - Phalangeal 15mm

Device Characteristics

• Single Use: No
• 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: No
• 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
KWD	Prosthesis, Toe, Hemi-, Phalangeal	Orthopedic	888.3730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33696	Partial metatarsophalangeal joint prosthesis	An implantable artificial substitute for the distal head of the metatarsal or the adjacent phalangeal base, intended to repair an articulating surface of the metatarsophalangeal (MTP) joint of the foot (toe). The device is made of metal or a metal/polymer combination, and may contain hyaluronic acid; implantation may be performed with or without bone cement. The device is intended to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850044114191	GS1

Premarket Submissions

Submission Number	Supplement Number
K200951	000