# K232251: APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Nov 3, 2023 after 98 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: 9 generations back to K962823 (1996). 80 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202589: APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System, Medartis AG (2020) Summary page 6.
- K133460: Aptus Cannulated Compression Screws, Medartis AG (2013) Summary page 6.
- K110658: Aptus Cannulated Compression Screws, Medartis AG (2011) Summary page 6.
- K092038: Aptus K-Wire System, Medartis AG (2009) Summary page 6.
- K230971: APTUS® 3.5 TriLock Straight Plates, Medartis AG (2023) Summary page 6.
- K963192: Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 6.

## Most influential descendants
- K260934: TITAN Nail; APTUS K-Wire System (2026), 0 descendants of its own

## Indications for use
APTUS® Cannulated Compression Screws and headed Cannulated Compression Screws are indicated for the treatment of fractures, osteotomies and arthrodesis of bones with the appropriate screw size in the shoulder, elbow, wrist, hand, knee, and the foot and ankle. 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/K232251
Methodology: https://510kreport.com/methodology