# K091951: Hammerlock

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Ent., Inc.
- Decided: Feb 19, 2010 after 233 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
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SmartToe: named in the summary without a submission number

## Most influential descendants
- K131640: Smooth or Threaded Metallic Bone Fastener (2013), 7 descendants of its own
- 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

## Indications for use
The HammerLockTM is indicated for small bone reconstruction and fusion such as in the phalanges of the fingers and toes.

Source page: https://510kreport.com/device/K091951
Methodology: https://510kreport.com/methodology