# K091609: Newdeal Compression Plate

- Pathway: 510(k) (Special)
- Applicant: Newdeal Sas
- Decided: Jun 30, 2009 after 27 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 K964226 (1997). 11 ancestors in all.
2 later devices descend 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)
- K070447: Newdeal Compression Plate, Newdeal Sas (2007) Summary page 2.

## Most influential descendants
- K161303: dynaMX™ Compression Plate (2017), 1 descendant of its own
- K193345: Arthrex DynaNite Compression Plate (2020), 0 descendants of its own

## Recalls of this device
- Nov 18, 2010 · Not classified · Z-0955-2011: Integra LifeSciences Corporation has decided to initiate a voluntary recall of the Uni-Comp Kits due to inaccurate information relative to the recommended sterilization parameters described in the pro

## Indications for use
The Newdeal Compression Plate is intended for fixation of bone fractures or for bone reconstruction. Examples include: * Arthrodesis in hand or foot surgery · Fracture management in the foot or hand * Mono or Bi-cortical osteotomies in the foot or hand . Distal or proximal metatarsal or metacarpal osteotomies * Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc) The size and number of the plate(s) used should be adapted to the specific indication.

Source page: https://510kreport.com/device/K091609
Methodology: https://510kreport.com/methodology