# K052152: B-Bop Plate

- Pathway: 510(k) (Traditional)
- Applicant: New Deal, S.A.
- Decided: Sep 13, 2005 after 36 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: 5 generations back to K000684 (2000). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040907: Arthrex Small Fragment Plates and Screws, Arthrex, Inc. (2004) Summary page 2.
- K012655: Congruent Bone Plate System, Acu Med, Inc. (2001) Summary page 2.
- K001941: Synthes Modular Foot System, Synthes (Usa) (2000) Summary page 2.

## Most influential descendants
- K063831: Basal Dorsal Plates (2007), 0 descendants of its own

## Indications for use
The B-BOP® 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/K052152
Methodology: https://510kreport.com/methodology