# K060474: Lisfranc Plate

- Pathway: 510(k) (Traditional)
- Applicant: New Deal, S.A.
- Decided: Aug 3, 2006 after 161 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K000684 (2000). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033639: Acumed Lower Extremity Congruent Plate System, Acumed, LLC (2004) Summary page 1.
- K010321: Modular Foot System - 2.7 MM Module, Synthes (Usa) (2001) Summary page 1.
- K001941: Synthes Modular Foot System, Synthes (Usa) (2000) Summary page 1.

## Most influential descendants
- K063820: Lisfranc Plate (2007), 0 descendants of its own

## Indications for use
The NEWDEAL Lisfranc Plates are intended for fractures, fusions, osteotomies and replantations of small bones at the tarsometatarsal joints (Lisfrane joints)

Source page: https://510kreport.com/device/K060474
Methodology: https://510kreport.com/methodology