# K112197: Memometal Intra-Medullary Bone Fastener

- Pathway: 510(k) (Special)
- Applicant: Memometal Technologies
- Decided: Nov 17, 2011 after 108 days
- Product code: HTY (Pin, Fixation, Smooth)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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: 3 generations back to K960385 (1996). 5 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070598: Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse, Memometal Technologies (2007) Summary page 1.

## Most influential descendants
- K201715: Smart Toe II, X Fuse (2020), 1 descendant of its own
- K253325: ZipToe™ Hammertoe Fusion System (2025), 0 descendants of its own
- K172485: Footmotion HammerToe (2018), 0 descendants of its own
- K150211: EzFuze Implant System (2015), 0 descendants of its own
- K143049: LYNC intramedullary implant (2015), 0 descendants of its own

## Recalls of this device
- Mar 28, 2022 · Class II · Z-1011-2022: The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead of "Not Indicated f

## Indications for use
The MEMOMETAL INTRAMEDULLARY 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/K112197
Methodology: https://510kreport.com/methodology