# K070447: Newdeal Compression Plate

- Pathway: 510(k) (Traditional)
- Applicant: Newdeal Sas
- Decided: Mar 29, 2007 after 42 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K964226 (1997). 10 ancestors in all.
102 later devices descend from it; 3 cite it directly.
0 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051908: Charlotte Compression Plate, Wrightmedicaltechnologyinc (2005) Summary page 1.
- K061594: Large Uni-Clip Staple, New Deal, S.A. (2006) Summary page 1.

## Most influential descendants
- K093914: Newdeal Compression Plates (2011), 98 descendants of its own
- K113014: Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws (2012), 97 descendants of its own
- K121651: Ortholoc 3DI Midfoot/Flatfoot System (2012), 95 descendants of its own
- K140397: Paralock Plating System / Tuffnek Screw (2014), 31 descendants of its own
- K143025: Total Compression Plating System (2014), 24 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
- Sep 30, 2008 · Not classified · Z-0307-2009: Reports of the Uni-CP Compression Forceps breaking during the Compression of the Uni-CP plate

## Indications for use
The Newdeal Compression Plate is indicated for fixation of bone fractures or for bone reconstruction. Examples include: - Arthrodesis in hand or foot surgery - Fractures 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 plate(s) used should be adapted to the specific indication.

Source page: https://510kreport.com/device/K070447
Methodology: https://510kreport.com/methodology