# K231496: TITAN 3-D Wedge System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: Aug 22, 2023 after 90 days
- Product code: PLF (Bone Wedge)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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 K093950 (2010). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162241: TITAN 3-D™ Wedge System, Paragon 28 (2017) Summary page 4.

## Indications for use
The TITAN 3-D® Wedge System implants are indicated to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the foot and ankle. The TITAN 3-D® Wedge System implants are intended for use with ancillary fixation. The TITAN 3-D® Wedge System implants are not indicated for use in the spine.

Source page: https://510kreport.com/device/K231496
Methodology: https://510kreport.com/methodology