# K022599: Newdeal K Wire

- Pathway: 510(k) (Traditional)
- Applicant: New Deal, S.A.
- Decided: Oct 30, 2002 after 86 days
- Product code: HTY (Pin, Fixation, Smooth)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960385 (1996). 2 ancestors in all.
118 later devices descend from it; 23 cite it directly.
0 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960385: Sterile Kirschner Wires and Steinmann Pins, Depuy, Inc. (1996) Summary page 2.
- K983121: Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220, Syntec Scientific Corp. (1998) Summary page 2.

## Most influential descendants
- K101165: Pro-Toe VO Hammertow Implant System (2010), 80 descendants of its own
- K070598: Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse (2007), 72 descendants of its own
- K120645: Pro-Toe (TM) VO Hamertoe Implant System-Line Sddition (2012), 61 descendants of its own
- K120165: Intraosseous Fixation System (2012), 35 descendants of its own
- K133636: Extremity Medical Hammertoe Device (2014), 31 descendants of its own

## Indications for use
NEWDEAL K WIRE is indicated for : - use in Fixation of bone fractures, - bone reconstruction, - as guide pins for insertion of other implants The size of the K WIRE should be adapted to the specific indication.

Source page: https://510kreport.com/device/K022599
Methodology: https://510kreport.com/methodology