# K112675: Arrow-Lok Digital System

- Pathway: 510(k) (Traditional)
- Applicant: Arrowhead Medical Device Technologies, LLC
- Decided: Dec 12, 2011 after 89 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: 5 generations back to K983121 (1998). 13 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100926: Arrowhead Fixation Device, Arrow Products, Inc. (2010) Summary page 1.
- K022599: Newdeal K Wire, New Deal, S.A. (2002) Summary page 1.
- K052736: Arthrex K-Wire ,Threaded Models AR-8990 to 899X, AR-8991T to AR-899XT, Arthrex, Inc. (2005) Summary page 1.

## Most influential descendants
- K183055: Vector Hammertoe Correction System (2019), 4 descendants of its own
- K201850: Vector Hammertoe Correction System (2020), 3 descendants of its own
- K213421: Vector® Hammertoe Correction System (2021), 2 descendants of its own
- K132912: Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal Implant (2014), 2 descendants of its own
- K231453: SnapHammer Hammertoe Correction System (2024), 1 descendant of its own

## Recalls of this device
- Jun 23, 2026 · Class II · Z-2958-2026: Implant indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures, did not undergo required gamma radiation dose audit. A potential reduc

## Indications for use
The ARROW-LOK implant is indicated for fixation of osteotomnies, arthrodeses and reconstruction in the lesser toes following corrective procedures. It is not intended for use in the spine.

Source page: https://510kreport.com/device/K112675
Methodology: https://510kreport.com/methodology