# K153207: Additive Orthopaedics Bone Wedge System

- Pathway: 510(k) (Traditional)
- Applicant: Additive Orthopaedics, LLC
- Decided: Sep 7, 2016 after 307 days
- Product code: HRS (Plate, Fixation, Bone)
- 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 K073535 (2008). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- K130185: 4WEB Osteotomy Bone Wedge, 4-Web, Inc. (2013) Summary page 4.

## Indications for use
The Additive Orthopaedics Bone 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 Additive Orthopaedics Bone Wedges are intended for use with ancillary plating fixation. The Additive Orthopaedics Bone Wedges are not intended for use in the spine.

Source page: https://510kreport.com/device/K153207
Methodology: https://510kreport.com/methodology