# K162179: osteo-WEDGE II ® Open Wedge Bone Locking Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Graham Medical Technologies, LLC Dba Gramedica
- Decided: Jan 10, 2017 after 159 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: 7 generations back to K000684 (2000). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111326: Osteowedge Opening Wedge Bone Locking System, Graham Medical Technologies, LLC (2011) Summary page 5.
- K061808: Darco Locking Bone Plate System, Darco International, Inc. (2006) Summary page 5.

## Indications for use
The osteo-WEDGE II ® Open 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/K162179
Methodology: https://510kreport.com/methodology