# K111326: Osteowedge Opening Wedge Bone Locking System

- Pathway: 510(k) (Traditional)
- Applicant: Graham Medical Technologies, LLC
- Decided: Jul 6, 2011 after 56 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 K000684 (2000). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061808: Darco Locking Bone Plate System, Darco International, Inc. (2006) Summary page 2.
- K052614: Low Profile Plate and Screw System, Arthrex, Inc. (2005) Summary page 2.

## Most influential descendants
- K162179: osteo-WEDGE II ® Open Wedge Bone Locking Plate System (2017), 0 descendants of its own

## Indications for use
The OsteoWedge M Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.

Source page: https://510kreport.com/device/K111326
Methodology: https://510kreport.com/methodology