# K032187: Anthrex Titanium Opening Wedge Osteotomy System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Sep 22, 2003 after 67 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
37 later devices descend from it; 3 cite it directly.
0 of 38 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
- K140397: Paralock Plating System / Tuffnek Screw (2014), 31 descendants of its own
- K170693: Phantom Small Bone Intramedullary Nail System (2017), 9 descendants of its own
- K182307: Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System (2019), 8 descendants of its own
- K170214: Additive Orthopaedics Locking Lattice Plate (2017), 8 descendants of its own
- K192163: TTC Phantom® Intramedullary Nail System (2020), 6 descendants of its own

## Recalls of this device
- Mar 11, 2021 · Class II · Z-1380-2021: It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.

## Indications for use
The Arthrex Titanium Opening Wedge Osteotomy System is used in conjunction with titanium bone screws to provide fixation following Proximal Tibial or Distal Femoral opening wedge osteotomies. The A/P sloped plates of the Arthrex Titanium Opening Wedge Osteotomy System are used following Proximal Tibial opening wedge osteotomies where tibial slope adjustments are required. Specifically for use in treatment of non-union, malunion, and fractures of proximal tibia and distal femur including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures. It is intended to be used with adequate post-operative immobilization.

Source page: https://510kreport.com/device/K032187
Methodology: https://510kreport.com/methodology