# K040356: Kompressor Screw System

- Pathway: 510(k) (Special)
- Applicant: Kinetikos Medical, Inc.
- Decided: Mar 1, 2004 after 17 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: 3 generations back to K962823 (1996). 8 ancestors in all.
255 later devices descend from it; 3 cite it directly.
1 of 264 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024233: Kompressor Screw System, Kinetikos Medical, Inc. (2003) Summary page 1.

## Most influential descendants
- K060071: Nexa Compression Screw (2006), 251 descendants of its own
- K063298: Osteomed Headless Cannulated Screw System (2007), 246 descendants of its own
- K111994: Smith & Nephew Cannulated Screws and Washers (2011), 161 descendants of its own
- K143039: CrossRoads Screw System (2015), 79 descendants of its own
- K162825: CAPTIVATE™ Compression Screws (2017), 74 descendants of its own

## Indications for use
The use of the Kompressor compression screw is generally indicated for the reduction and fixation of fractures appropriate for the size of the device. It is indicated for use in the internal fixation of fractures, fusion, and revision. It is also indicated for reconstructive procedures where reduction and fixation of bone fragments is required (e.g. osteotomies). Contraindications would include any conditions which would contraindicate implants in general, including: : Infection : Metal sensitivity or allergic reaction to foreign bodies : Any concomitant disease which may compromise the function of the implant * In those cases where avascular necrosis has rendered bone stock inadequate

Source page: https://510kreport.com/device/K040356
Methodology: https://510kreport.com/methodology