# K180239: Additive Orthopaedics Patient Specific 3D Printed Bone Segments

- Pathway: 510(k) (Traditional)
- Applicant: Additive Orthopaedics, LLC
- Decided: May 16, 2018 after 107 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K162016: Affinity NT Oxygenator with Cortiva BioActive Surface, Medtronic, Inc. (2016). Our OCR of the scanned summary read K162016, FDA’s number for Affinity NT Oxygenator with Cortiva BioActive Surface (Medtronic, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Additive Orthopaedics, LLC Bone Wedge System”. Kept off the family tree.

## Indications for use
The Additive Orthopaedics 3D Printed Bone Segments 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 3D Printed Bone Segments are intended for use with ancillary plating fixation. The Additive Orthopaedics 3D Printed Bone Segments are not intended for use in the spine. It is a patient specific device.

Source page: https://510kreport.com/device/K180239
Methodology: https://510kreport.com/methodology