# K131640: Smooth or Threaded Metallic Bone Fastener

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Ent., Inc.
- Decided: Oct 16, 2013 after 134 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). 6 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091951: Hammerlock, Biomedical Ent., Inc. (2010) Summary page 1.
- K070598: Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse, Memometal Technologies (2007) Summary page 2.

## Most influential descendants
- K133520: Hammerlock 2 (2014), 5 descendants of its own
- K170326: dynaMX Intramedullary Implant (2017), 2 descendants of its own
- K190287: Arthrex DynaNite® PIP (Hammertoe) Implant (2019), 1 descendant of its own
- K231147: Hammerdesis™ Interphalangeal Fusion System (2023), 0 descendants of its own
- K191463: DePuy Synthes Hammertoe Continuous Compression Implant (2020), 0 descendants of its own

## Indications for use
The HammerLock®R is indicated for: Small bone reconstruction and fusion such as inter-digital fusion of fingers and toes.

Source page: https://510kreport.com/device/K131640
Methodology: https://510kreport.com/methodology