# K103332: Aptus Ulna Plates

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Jan 24, 2011 after 73 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: 5 generations back to K962616 (1996). 18 ancestors in all.
71 later devices descend from it; 12 cite it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051567: Aptus Titanium Osteosynthesis System, Medartis, Inc. (2005) Summary page 2.
- K092038: Aptus K-Wire System, Medartis AG (2009) Summary page 2.
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 2.
- K033805: Synthes (Usa) 3.5 / 4.5 MM LCP Metaphyseal Plates, Synthes (Usa) (2004) Summary page 2.

## Most influential descendants
- K142906: APTUS Wrist 2.5 System (2015), 59 descendants of its own
- K163361: ANTHEM™ Fracture System (2017), 14 descendants of its own
- K173166: ANTHEM Fracture System (2017), 11 descendants of its own
- K180554: ANTHEM Fracture System (2018), 10 descendants of its own
- K213864: Bonebridge Osteosynthesis Plating System (2022), 8 descendants of its own

## Indications for use
APTUS® Ulna Plates are indicated for fractures and osteotomnies, in particular for the ulna.

Source page: https://510kreport.com/device/K103332
Methodology: https://510kreport.com/methodology