# K142707: AIS Odontoid Fracture Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant System, Inc.
- Decided: Dec 19, 2014 after 88 days
- Product code: HWC (Screw, Fixation, Bone)
- 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 K792022 (1979). 10 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K970549: Titanium Alloy Bone Screws, Aesculap, Inc. (1997) Summary page 4.
- K020791: HBS Headless Bone Screw, Millennium Medical Technologies, Inc. (2002) Summary page 5.
- K132910: Depuy Synthes Spine Dens Access System, Synthes USA Products, LLC (2013) Summary page 5.

## Most influential descendants
- K192744: CORRIDOR Fixation System (2019), 2 descendants of its own
- K250920: Arthrex Spine Compression FT Screw (2025), 1 descendant of its own
- K262618: Arthrex Spine Compression FT Screw (2026), 0 descendants of its own

## Indications for use
For fracture fixation of small bones and small bone fragments including odontoid fractures.

Source page: https://510kreport.com/device/K142707
Methodology: https://510kreport.com/methodology