# K112169: Aptus Wrist Arthrodesis Plates

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Jan 6, 2012 after 162 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). 21 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990094: Kmi Wrist Fusion System, Kinetikos Medical, Inc. (1999) Summary page 2.
- K023879: Small Titanium Wrist Fusion Plate, Synthes (Usa) (2003) Summary page 2.
- K042355: Synthes (Usa) LCP Wrist Fusion Plates, Synthes (Usa) (2004) Summary page 2.
- K011458: Synthes Straight Wrist Fusion Plate, 170MM, Synthes (Usa) (2001)
- K000558: Synthes (Usa) Wrist Fusion Plates (WFP), Synthes (Usa) (2000) Summary page 2.
- K051567: Aptus Titanium Osteosynthesis System, Medartis, Inc. (2005) Summary page 2.

## Most influential descendants
- K192297: APTUS Wrist Arthrodesis Plates (2019), 7 descendants of its own
- K223853: Medartis APTUS® Ulna Plates (2023), 5 descendants of its own
- K234062: APTUS Hand Scaphoid Plates (2024), 3 descendants of its own
- K232144: Sterile Products of the APTUS System (2023), 3 descendants of its own
- K243610: APTUS Hand System; APTUS Elbow Dorsal Olecranon (2025), 2 descendants of its own

## Indications for use
APTUS® Wrist Arthrodesis Plates are indicated for wrist arthrodesis.

Source page: https://510kreport.com/device/K112169
Methodology: https://510kreport.com/methodology