# K202589: APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System

- Pathway: 510(k) (Traditional)
- Applicant: Medartis AG
- Decided: Nov 6, 2020 after 59 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K962823 (1996). 49 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K050681: Omnitech System & Easy Lock Osteosystem with Xtremities Plates, TriMed, Inc. (2005) Summary page 6.
- K963192: Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 6.

## Most influential descendants
- 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
- K234040: TriMed Threaded Intramedullary Nail System (2024), 0 descendants of its own

## Recalls of this device
- Apr 24, 2026 · Class II · Z-2361-2026: The cannulation of the CCS screw is not centered.

## Indications for use
APTUS® Cannulated Compression Screws and headed Cannulated Compression Screws are intended 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/K202589
Methodology: https://510kreport.com/methodology