# K201314: Restor3d Utility Wedge

- Pathway: 510(k) (Traditional)
- Applicant: Restor3D, Inc.
- Decided: Jun 17, 2021 after 395 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: 5 generations back to K093950 (2010). 11 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191047: ADI TiDAL Osteotomy Wedge, Additive Device, Inc. (Adi) D/B/A Restor3D (2019) Summary page 4.
- K172294: Osteotomy Truss System (OTS), 4Web, Inc. (2018) Summary page 4.

## Most influential descendants
- 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
- K251791: Auxano® Wedge Fixation System (2025), 0 descendants of its own

## Indications for use
The restor3d Utility Wedges are intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus • Opening wedge of Medial Cuneiform or Cotton osteotomies • Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy) • Metatarsal Cuneiform osteotomies • Nonunion of arthrodesis of the Midfoot including Metatarsal Cuneiform osteotomies (TMT or Lapidus) • Hindfoot osteotomies such as Ankle fusion and Subtalar fusion The restor3d Utility Wedges are intended for use with supplemental fixation. The restor3d Utility Wedges are not intended for use in the spine.

Source page: https://510kreport.com/device/K201314
Methodology: https://510kreport.com/methodology