Device
Implants: This system is indicated for the lengthening arthrodesis of the metatarsophalangeal joint. 18mm diameter and 22mm diameter footprints are provided, in heights of 8mm, 10m...
Manufacturer
NVISION BIOMEDICAL TECHNOLOGIES, INC.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
Model: MTP-22-12-00
DI: 00810005668118
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
Description
Implants: This system is indicated for the lengthening arthrodesis of the metatarsophalangeal joint. 18mm diameter and 22mm diameter footprints are provided, in heights of 8mm, 10mm, and 12mm to accommodate for a wide patient population, allowing for precise and reliable application. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot.
The Trigon MTP Wedge System can be combined with ancillary fixation via the staples provided.
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3aa48a37-cd82-42a4-919d-3ef5d7e7c97e
Distribution Status:
In Commercial Distribution
DUNS Number:
047486041
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00810005668118
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 33696
Name: Partial metatarsophalangeal joint prosthesis
Definition:
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.
FDA Product Codes
KWD
Prosthesis, Toe, Hemi-, Phalangeal