AccessGUDID - DEVICE: K2™ Hemi Toe Implant System (10381780065579)

GUDID

Device Identifier (DI) Information

Brand Name: K2™ Hemi Toe Implant System
Version or Model: 201040
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 201040
Company Name: INTEGRA LIFESCIENCES CORPORATION

Primary DI Number: 10381780065579
Issuing Agency: GS1
Commercial Distribution End Date: December 04, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 963856096 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWD	Prosthesis, Toe, Hemi-, Phalangeal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: 5cf2f796-e4f7-4f5b-b3a4-2a56fb81f693
Public Version Date: March 18, 2024
Public Version Number: 6
DI Record Publish Date: October 09, 2017