# K070598: Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse

- Pathway: 510(k) (Traditional)
- Applicant: Memometal Technologies
- Decided: Jul 26, 2007 after 146 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: 2 generations back to K960385 (1996). 4 ancestors in all.
72 later devices descend from it; 14 cite it directly.
0 of 77 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 1.
- K964226: Memory Staple (20 Sizes Available), Landos, Inc. (1997) Summary page 1.

## Most influential descendants
- K120165: Intraosseous Fixation System (2012), 35 descendants of its own
- K133636: Extremity Medical Hammertoe Device (2014), 31 descendants of its own
- K141857: CrossTie Intraosseous Fixation System (2015), 16 descendants of its own
- K110445: Flexfusion (TM) Fixation Implant (2011), 16 descendants of its own
- K151270: CrossTIE Intraosseous Fixation System (2015), 15 descendants of its own

## Indications for use
The MEMOMETAL INTRA MEDULLARY BONE FASTENER (SMART TOE / X-FUSE) are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bones fusion

Source page: https://510kreport.com/device/K070598
Methodology: https://510kreport.com/methodology