# K083154: Newdeal Hallu Lock Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Newdeal Sas
- Decided: Jul 10, 2009 after 259 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: 4 generations back to K000684 (2000). 11 ancestors in all.
2 later devices descend from it; 2 cite 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.

## Most influential descendants
- K093781: Modified: Newdeal Hallu Plates (2010), 1 descendant of its own
- 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

## Recalls of this device
- Dec 21, 2011 · Not classified · Z-1147-2012: Manufacturing error. The part number which corresponds to the length dimension of : 14 mm. was incorrectly etched on to screws with the actual measurement of: 12 mm.

## Indications for use
The HALLU® Lock Plates are intended for fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint. Including cases of: - Hallux rigidus - Severe hallux valgus (IM angle >200 and HV angle >400) - Deformity from rheumatoid arthritis - Failed previous surgical procedure - Traumatic arthritis - Neuromuscular instability. The HALLU® Lock plates must be fixed with the SURFIX ® fixed angle locking system and with the SURFIX®-Alpha variable angle locking system of 2.7mm or 3.0mm diameter (screws and lock-screws). Addition of a Newdeal® QWIX® screw crossing the joint is strongly recommended for optimal arthrodesis consolidation

Source page: https://510kreport.com/device/K083154
Methodology: https://510kreport.com/methodology