# K090053: Aptus 2.0 Radial Head System

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Apr 23, 2009 after 105 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.
8 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K130774: Universal Distal Radius System (2013), 5 descendants of its own
- K142502: Alians Ulna Locking Plating System (2014), 2 descendants of its own
- K211592: Avanti Orthopaedics Ulnar Shortening System (2021), 1 descendant of its own
- K170843: Alians Fragment Specific (2017), 1 descendant of its own
- K261145: Avanti Distal Elbow ORIF System (2026), 0 descendants of its own

## Indications for use
The APTUS ® 2.0 Radial Head System is intended for use in proximal radial fractures and osteotomies.

Source page: https://510kreport.com/device/K090053
Methodology: https://510kreport.com/methodology