# K051309: Roi Fusion Rods & Plates

- Pathway: 510(k) (Traditional)
- Applicant: Reiley Orthopaedics, Inc.
- Decided: Jul 11, 2005 after 53 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930834 (1993). 3 ancestors in all.
145 later devices descend from it; 1 cites it directly.
0 of 149 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010783: 2.0/2.4 Cannulated Screw System, Osteomed Corp. (2001) Summary page 1.
- K930834: Acutract, Acu Med, Inc. (1993) Summary page 1.
- K944330: Acutrak Plus Fixation System, Acu Med, Inc. (1995) Summary page 1.

## Most influential descendants
- K080398: SI Joint Fusion System (2008), 144 descendants of its own
- K110838: Ifuse Implant System (2011), 143 descendants of its own
- K122074: Ifuse Implant System (2012), 139 descendants of its own
- K123850: Ifuse Implant System (2013), 134 descendants of its own
- K131405: Ifuse Implant System (2013), 133 descendants of its own

## Recalls of this device
- Apr 20, 2011 · Not classified · Z-2589-2011: Two lots- one lot of Endo-Fuse Fusion Rod, 7x50mm was commingled one lot of Endo-Fuse(R) Fusion Rod, 7x70mm. Not all parts in each lot are affected. The commingled rod sizes might not be detected prio
- Apr 20, 2011 · Not classified · Z-2590-2011: Two lots- one lot of Endo-Fuse Fusion Rod, 7x50mm was commingled one lot of Endo-Fuse(R) Fusion Rod, 7x70mm. Not all parts in each lot are affected. The commingled rod sizes might not be detected prio

## Indications for use
The use of the ROI Fusion Rods and Plates are generally indicated for the reduction and fixation of fractures appropriate for the size of the devices. They are indicated for use in the internal fixation of fractures, boney fusion, and non-unions. They are also indicated for reconstructive procedures where reduction and fixation of bone fragments are required (e.g. osteotomies).

Source page: https://510kreport.com/device/K051309
Methodology: https://510kreport.com/methodology