# K190543: Cannulated Hemi Implant

- Pathway: 510(k) (Traditional)
- Applicant: Vilex IN Tennessee, Inc.
- Decided: May 31, 2019 after 88 days
- Product code: KWD (Prosthesis, Toe, Hemi-, Phalangeal)
- Device class: 2
- Regulation: 21 CFR 888.3730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K864492 (1987). 25 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023684: Cannulated Metallic Hemi Toe Implant, Models MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365, Vilex, Inc. (2004) Summary page 4.
- K070052: Met-Head Model# MHDD-XX:CC Diameter, CC Cannulation, Vilex, Inc. (2007) Summary page 4.
- K102401: Hemi Implant; Mini Hemi Implant, Vilex, Inc. (2011) Summary page 4.
- K152454: HemiCAP MTP Resurfacing Hemi-Arthroplasty System, Arthrosurface, Inc. (2016) Summary page 4.
- K031859: Cap Great Toe Resurfacing Hemi-Arthroplasty Implant, Arthrosurface, Inc. (2004) Summary page 4.
- K132496: Arthrosurface Toemotion, Arthrosurface, Inc. (2014) Summary page 4.

## Most influential descendants
- K203634: BioPoly Great Toe Hemiarthroplasty Implant (2021), 2 descendants of its own
- K222964: BioPoly Lesser Toe Hemiarthroplasty Implant (2022), 1 descendant of its own
- K200951: Accu-Joint Hemi Implant (2020), 1 descendant of its own
- K233592: BioPoly Radial Head Implant (2024), 0 descendants of its own
- K240268: Accu-Joint Hemi Implant (2024), 0 descendants of its own

## Indications for use
The Vilex CHI (cannulated hemi implant), a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions: Hallux Limitus, Hallux Valgus, Hallux Rigidus, and an unstable or painful MTP joint. The Vilex cannulated metallic hemi implant is intended to be used with bone cement. The Vilex cannulated metallic hemi implant is intended for single-use only.

Source page: https://510kreport.com/device/K190543
Methodology: https://510kreport.com/methodology