# K133460: Aptus Cannulated Compression Screws

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Dec 18, 2013 after 36 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: 7 generations back to K962823 (1996). 29 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092038: Aptus K-Wire System, Medartis AG (2009) Summary page 2.
- K110658: Aptus Cannulated Compression Screws, Medartis AG (2011)
- K080943: Synthes 4.5 MM and 6.5 MM Headless Compression Screws, Synthes (Usa) (2008) Summary page 2.
- K962011: Synthes 7.0/7.3 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 2.
- K080850: Darco Headless Compression Screw, Wrightmedicaltechnologyinc (2008) Summary page 2.

## Most influential descendants
- K202589: APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System (2020), 6 descendants of its own
- K211783: TriMed Threaded Intramedullary Nail System (2021), 2 descendants of its own
- K232251: APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension (2023), 1 descendant of its own
- K230749: TriMed Threaded Intramedullary Nail System (2023), 1 descendant of its own
- K260934: TITAN Nail; APTUS K-Wire System (2026), 0 descendants of its own

## Indications for use
APTUS® Cannulated Compression Screws 5.0, 7.0 are intended for the treatment of fractures, osteotomies and arthrodeses of bones with the appropriate screw size.

Source page: https://510kreport.com/device/K133460
Methodology: https://510kreport.com/methodology