# K100926: Arrowhead Fixation Device

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Products, Inc.
- Decided: Oct 29, 2010 after 207 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: 4 generations back to K983121 (1998). 12 ancestors in all.
10 later devices descend from it; 1 cites 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)
- 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.
- K072710: Nexfix Compression Pin, Nexa Orthopedics, Inc. (2007) Summary page 1.
- K963433: Threaded Fixation Pin, Orthopaedic Biosystems, Ltd. (1996) Summary page 1.
- K101165: Pro-Toe VO Hammertow Implant System, Wrightmedicaltechnologyinc (2010). Cleared while this submission was under review
- K100414: Protoe Endosorb Small Hammer Toe Pin, Merete Medical GmbH (2010). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K112675: Arrow-Lok Digital System (2011), 9 descendants of its own
- 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

## Indications for use
The Arrowhead is indicated for fixation of osteotomies, 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/K100926
Methodology: https://510kreport.com/methodology