K2™ Hemi Toe Implant System

Basic Information

• Brand Name: K2™ Hemi Toe Implant System
• Primary DI: 10381780065579
• Version / Model: 201040
• Catalog Number: 201040
• Company Name: INTEGRA LIFESCIENCES CORPORATION
• Labeler DUNS: 963856096
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-09
• Public Version: 5
• Public Version Date: 2022-02-21
• Public Version Status: Update
• Public Device Record Key: 5cf2f796-e4f7-4f5b-b3a4-2a56fb81f693

Device Description

The K2 Hemi Toe implant is intended for cement fixation by means of a stem, which is inserted into the medullary canal of the phalanx. It is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.

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: Yes
• 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
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
Secondary	M248201040KMI1	HIBCC
Primary	10381780065579	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K023770	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			17.4 mm dia x 14.7 mm L; Size 4

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store unopened in respective package until use. Avoid contact with any objects that may damage the surface finish.