# K162154: Pantheon Medical Balanced Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Pantheon Medical
- Decided: Apr 24, 2017 after 265 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: 1 generation back to K050657 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072740: Mondeal Extremity Bone Fixation System, Mondeal Medical Systems GmbH (2007) Summary page 4.
- K050657: Mondeal Contour HO System, Kapp Surgical Instrument, Inc. (2005) Summary page 4.

## Indications for use
The Pantheon Medical Balanced Plating System is intended for fixation of fractures, revision procedures, joint fusion, non-unions, and reconstruction of orthopedic small bone extremities. This system is not intended for spinal use.

Source page: https://510kreport.com/device/K162154
Methodology: https://510kreport.com/methodology