# K063831: Basal Dorsal Plates

- Pathway: 510(k) (Traditional)
- Applicant: Newdeal Sas
- Decided: Feb 7, 2007 after 43 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: 6 generations back to K000684 (2000). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052152: B-Bop Plate, New Deal, S.A. (2005) Summary page 1.
- K033639: Acumed Lower Extremity Congruent Plate System, Acumed, LLC (2004) Summary page 1.

## Indications for use
The Basal Dorsal Plate is intended for fixation of osteotomy of the basis of the first metatarsal. Examples include: - Moderate to severe Hallux Valgus - Hallux varus

Source page: https://510kreport.com/device/K063831
Methodology: https://510kreport.com/methodology