# K201430: InFrame™ Cannulated Fixation System

- Pathway: 510(k) (Special)
- Applicant: Exsomed Corp.
- Decided: Jun 20, 2020 after 19 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: 13 generations back to K962616 (1996). 111 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 113 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 5.
- K183603: INnate Cannulated Screw System, Exsomed Corporation (2019) Summary page 5.
- K161904: GEO Bone Screw System, Gramercy Extremity Orthopeidics, LLC (2017) Summary page 5.

## Most influential descendants
- K220892: ExsoMed INnate NanoTM Lag Screw System (2022), 0 descendants of its own

## Indications for use
The ExsoMed InFrame™ Cannulated Fixation 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/K201430
Methodology: https://510kreport.com/methodology