# K103623: Newdeal Interphalangeal Implant

- Pathway: 510(k) (Traditional)
- Applicant: Newdeal Sas
- Decided: Mar 20, 2012 after 466 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: 3 generations back to K960385 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022599: Newdeal K Wire, New Deal, S.A. (2002) Summary page 2.
- K070598: Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse, Memometal Technologies (2007) Summary page 2.
- K100414: Protoe Endosorb Small Hammer Toe Pin, Merete Medical GmbH (2010) Summary page 2.

## Indications for use
The Newdeal Interphalangeal Implant is intended for fixation of proximal interphalangeal joint arthrodesis of the lesser toes. Examples include: * rigid or semi-rigid hammertoe deformity * revision of failed arthroplasty or arthrodesis. * 2nd toe shortening

Source page: https://510kreport.com/device/K103623
Methodology: https://510kreport.com/methodology