# K211076: Patient Specific Marking Guides

- Pathway: 510(k) (Traditional)
- Applicant: Additive Orthopaedics, LLC
- Decided: Jun 28, 2022 after 442 days
- Product code: PBF (Orthopaedic Surgical Planning And Instrument Guides)
- 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: 1 generation back to K190044 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190044: VSP Orthopedics System, 3D Systems, Inc. (2019) Summary page 4.

## Indications for use
The Paragon 28 Patient Specific Marking Guide is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, non-joint replacing osteotomies for adult patients in the foot and ankle. The Patient Specific Guide is not intended to directly guide the cutting of bone. The device is single use only.

Source page: https://510kreport.com/device/K211076
Methodology: https://510kreport.com/methodology