# K260934: TITAN Nail; APTUS K-Wire System

- Pathway: 510(k) (Special)
- Applicant: Medartis AG
- Decided: Apr 17, 2026 after 28 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K962823 (1996). 81 ancestors in all.
No later device cites it as a predicate yet.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232251: APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension, Medartis AG (2023) Summary page 5.
- K202589: APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System, Medartis AG (2020) Summary page 5.

## Indications for use
APTUS Cannulated Compression Screws and headed Cannulated Compression Screws, including TITAN Nails, are indicated for the treatment of fractures, osteotomies and arthrodesis of bones with the appropriate screw size. APTUS K-Wire System Is intended for use In fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.

Source page: https://510kreport.com/device/K260934
Methodology: https://510kreport.com/methodology