# K162241: TITAN 3-D™ Wedge System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28
- Decided: Apr 3, 2017 after 236 days
- Product code: PLF (Bone Wedge)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K093950 (2010). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142724: BIOFOAM Bone Wedge, Wrightmedicaltechnologyinc (2015) Summary page 4.
- K130185: 4WEB Osteotomy Bone Wedge, 4-Web, Inc. (2013) Summary page 4.

## Most influential descendants
- K252733: ATLAS™ Expandable Osteotomy Wedge System (2026), 0 descendants of its own
- K231496: TITAN 3-D Wedge System (2023), 0 descendants of its own

## Recalls of this device
- Sep 28, 2018 · Class II · Z-0662-2020: It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge implant is a 10mm size and is permanently marked as a 12mm size. Use of the product could res

## Indications for use
The TITAN 3-D™ Wedge System implants are intended 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 intended for use in the spine.

Source page: https://510kreport.com/device/K162241
Methodology: https://510kreport.com/methodology