# K970549: Titanium Alloy Bone Screws

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Apr 30, 1997 after 77 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: 1 generation back to K912598 (1991). 2 ancestors in all.
26 later devices descend from it; 3 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930107: Ame Universal Bone Screw, American Medical Electronics, Inc. (1994) Summary page 2.
- K912598: Ace Cortical Bone Screw, Ace Medical Co. (1991) Summary page 2.
- (no number) Aesculap’s current line of bone screws: named in the summary without a submission number

## Most influential descendants
- K023365: Leforte System Bone Screw (2003), 20 descendants of its own
- K131311: Arix Foot System (2013), 9 descendants of its own
- K050669: Jeil Bone Fixation System (2005), 8 descendants of its own
- K161864: ARIX Foot System (2016), 5 descendants of its own
- K172260: Omni Foot Plating System (2017), 4 descendants of its own

## Indications for use
The titanium alloy cortical bone screws presented in this submission are intended for long and small bone fracture fixation.

Source page: https://510kreport.com/device/K970549
Methodology: https://510kreport.com/methodology