# K160791: AmorChem Titanium Porous Fixation Device

- Pathway: 510(k) (Traditional)
- Applicant: Amorchem Holdings, Inc.
- Decided: Nov 15, 2016 after 237 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: 11 generations back to K960978 (1996). 81 ancestors in all.
No later device cites it as a predicate yet.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143618: Kirschner Wires, Steinmann Pins, Zimmer, Inc. (2015) Summary page 4.
- K930834: Acutract, Acu Med, Inc. (1993) Summary page 4.
- K102528: N-Force Fixation System, Innovision, Inc. (2011) Summary page 4.

## Indications for use
The AmorChem 3.8 mm Headless Porous Titanium Compression Screw is used for fixation of bone fractures, bone reconstruction, and fixation of osteotomies.

Source page: https://510kreport.com/device/K160791
Methodology: https://510kreport.com/methodology