# K014155: Opening/Closing Wedge Ostetomy Plates

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Mar 18, 2002 after 89 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
No predicates in its family tree.
13 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K150456: Arthrex Plates, Screws, and Staples (2015), 6 descendants of its own
- K041601: Surfix Knee Osteotomy System (2004), 5 descendants of its own
- K141548: High Tibial Osteotomy System (2015), 3 descendants of its own
- K250920: Arthrex Spine Compression FT Screw (2025), 1 descendant of its own
- K222267: Arthrex 2.4 mm Volar Distal Radius Plate System (2022), 1 descendant of its own

## Indications for use
The Arthrex Modified Osteotomy System, designed for Opening Wedge Distal Tibial, Distal Femoral, Proximal Tibial osteotomies, and High Tibial Closing Osteotomies, is used in conjunction with bone screws to provide fixation following surgery. Specifically for use in treatment of non-union, malunion, and fractures of proximal tibia, distal femur, and distal tibia including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. Specially sloped plates can be used in cases when a tibial slope adjustment is needed. This system consists of plates and screws which join together to correct abnormalities or trauma related injuries. It is intended to be used with adequate post-operative immobilization.

Source page: https://510kreport.com/device/K014155
Methodology: https://510kreport.com/methodology