# K163593: Additive Orthopaedics Bunion System

- Pathway: 510(k) (Traditional)
- Applicant: Additive Orthopaedics, LLC
- Decided: Jun 20, 2017 after 181 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: 11 generations back to K954385 (1996). 156 ancestors in all.
No later device cites it as a predicate yet.
0 of 157 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131061: Restore Bunion Correction System, Nextremity Solutions (2013) Summary page 4.
- K120157: Mini Maxlock Extreme Plating System, Orthohelix Surgical Designs, Inc. (2012) Summary page 4.
- K131445: Osteomed Extremilock Foot Plating System, Osteomed LP (2013) Summary page 4.
- K141784: Ortho Solutions Ultos Plating System, Ortho Solutions Limited (2014) Summary page 4.

## Indications for use
The Additive Orthopaedics Bunion System is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle.

Source page: https://510kreport.com/device/K163593
Methodology: https://510kreport.com/methodology