# K183603: INnate Cannulated Screw System

- Pathway: 510(k) (Special)
- Applicant: Exsomed Corporation
- Decided: Mar 12, 2019 after 76 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: 2 generations back to K000080 (2000). 3 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171558: ExsoMed ITN Cannulated Screw System, Exsomed Holdings Company, LLC (2017) Summary page 4.
- K050636: Synthes 3.0MM Headless Compression Screws, Synthes (Usa) (2005) Summary page 4.

## Most influential descendants
- K201430: InFrame™ Cannulated Fixation System (2020), 1 descendant of its own
- K252312: Eleganz IM Threaded Nail System (IM Threaded Nail System) (2025), 0 descendants of its own
- K223761: OIC Intramedullary Screw System (2023), 0 descendants of its own
- K222799: Haymaker® Screw System (2023), 0 descendants of its own
- K220892: ExsoMed INnate NanoTM Lag Screw System (2022), 0 descendants of its own

## Indications for use
The ExsoMed INnate Cannulated Screw System is intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

Source page: https://510kreport.com/device/K183603
Methodology: https://510kreport.com/methodology