# K070241: Modification to Lapidus Plate

- Pathway: 510(k) (Special)
- Applicant: New Deal, S.A.
- Decided: Feb 8, 2007 after 14 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K000684 (2000). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060476: Lapidus Plate, New Deal, S.A. (2006) Summary page 1.

## Recalls of this device
- Feb 9, 2012 · Class II · Z-2123-2012: Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during surgery.

## Indications for use
The NEWDEAL Lapidus Plates are intended to be used for bone fixation such as: - Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus - Lisfranc arthrodesis - Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint.

Source page: https://510kreport.com/device/K070241
Methodology: https://510kreport.com/methodology