# K093781: Modified: Newdeal Hallu Plates

- Pathway: 510(k) (Special)
- Applicant: Newdeal Sas
- Decided: Jan 22, 2010 after 44 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). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021626: Hallu Plates, New Deal, S.A. (2002) Summary page 2.
- K083154: Newdeal Hallu Lock Plate System, Newdeal Sas (2009) Summary page 2.

## Most influential descendants
- K210016: Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System (2021), 0 descendants of its own

## Indications for use
The HALLU PLATES are intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metatarsophalangeal joint, including cases of: • Hallux rigidus • Severe hallux valgus (IM angle >20° and HV angle >40°) • Deformity from rheumatoid arthritis • Failed previous surgical procedure • Traumatic arthritis • Neuromuscular instability Addition of a screw crossing the joint is strongly recommended for optimal arthrodesis consolidation.

Source page: https://510kreport.com/device/K093781
Methodology: https://510kreport.com/methodology