# K191047: ADI TiDAL Osteotomy Wedge

- Pathway: 510(k) (Traditional)
- Applicant: Additive Device, Inc. (Adi) D/B/A Restor3D
- Decided: Nov 5, 2019 after 200 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: 2 generations back to K093950 (2010). 2 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131360: Integra Titanium Bone Wedge, Ascension Orthopedic (2013) Summary page 4.

## Most influential descendants
- K201314: Restor3d Utility Wedge (2021), 7 descendants of its own
- K220197: Trigon HA Wedge Fixation System (2022), 4 descendants of its own
- K243231: Trigon PEEK HA Wedges (2024), 1 descendant of its own
- K252733: ATLAS™ Expandable Osteotomy Wedge System (2026), 0 descendants of its own
- K252254: Osteotomy Wedge System (2025), 0 descendants of its own

## Indications for use
The TiDAL Osteotomy Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: Cotton (opening wedge) osteotomies of the medial cuneiform Evans lengthening osteotomies. The TiDAL Osteotomy Wedges are intended for use with ancillary plating fixation. The TiDAL Osteotomy Wedges are not intended for use in the spine.

Source page: https://510kreport.com/device/K191047
Methodology: https://510kreport.com/methodology