# K111419: Osteomed Hand Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed LP
- Decided: Oct 7, 2011 after 140 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K962823 (1996). 29 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063298: Osteomed Headless Cannulated Screw System, Osteomed LP (2007) Summary page 2.
- K090522: Osteomed Hand Plate and Screw Fixation System, Osteomed LP (2009) Summary page 2.
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 2.
- K030310: Synthes Stainless Steel Modular Hand System, Synthes (Usa) (2003) Summary page 2.

## Most influential descendants
- K130120: Extremity Medical IP Fusion System (2013), 0 descendants of its own

## Indications for use
OsteoMed Hand Fusion System is intended for use in bone fusion and arthrodesis of phalanges and metacarpals. It is intended for use in trauma, general surgery and reconstructive procedure. The OsteoMed Hand Fusion System implants are intended for single use only.

Source page: https://510kreport.com/device/K111419
Methodology: https://510kreport.com/methodology