# K200951: Accu-Joint Hemi Implant

- Pathway: 510(k) (Traditional)
- Applicant: Accufix Surgical, Inc.
- Decided: Dec 8, 2020 after 243 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: 10 generations back to K864492 (1987). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190543: Cannulated Hemi Implant, Vilex IN Tennessee, Inc. (2019) Summary page 5.
- K102401: Hemi Implant; Mini Hemi Implant, Vilex, Inc. (2011) Summary page 5.
- K070052: Met-Head Model# MHDD-XX:CC Diameter, CC Cannulation, Vilex, Inc. (2007) Summary page 5.
- K023684: Cannulated Metallic Hemi Toe Implant, Models MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365, Vilex, Inc. (2004) Summary page 5.
- K121973: Biopro Hemi-Edge Toe System, Biopro, Inc. (2012) Summary page 5.

## Most influential descendants
- K240268: Accu-Joint Hemi Implant (2024), 0 descendants of its own

## Indications for use
The Accu-Joint Hemi Implant, a hemi-arthroplasty metatarsal head or phalangeal base 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, along with the following clinical conditions: Hallux Limitus, Hallux Valgus, Hallux Rigidus, and an unstable or painful MTP joint. The Accu-Joint Hemi Implant is intended to be used with bone cement. The metatarsal head and phalangeal base may not be used together at the same joint.

Source page: https://510kreport.com/device/K200951
Methodology: https://510kreport.com/methodology