# K202803: Activmotion S DTO

- Pathway: 510(k) (Traditional)
- Applicant: Newclip Technics
- Decided: Dec 16, 2021 after 449 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 K000684 (2000). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073375: Newdeal Tibiaxys System, Newdeal Sas (2008) Summary page 5.
- K113652: Loqteq Small Fragment Set Loqteq Cortical SCREW3.5, Small Head, T15, Self Tapping Loqteq Cortical Screw 3.5, T15, Self T, Aap Implantate AG (2012) Summary page 5.

## Indications for use
The implants of the Activmotion S DTO range are intended for bone reconstruction of the ankle joint in adults, including fixation of fractures and osteotomies of ankle, distal tibia and fibula.

Source page: https://510kreport.com/device/K202803
Methodology: https://510kreport.com/methodology