# K090289: Clavicle Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Orthohelix Surgical Designs, Inc.
- Decided: Jun 15, 2009 after 130 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.
340 later devices descend from it; 2 cite it directly.
0 of 341 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
- K100618: Maxlock Extreme Extremity Plating System with Variable Angle Technology (2010), 339 descendants of its own
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System (2010), 228 descendants of its own
- K102156: Maxlock Extreme Extremity Plating System Distal Radius Plates and Screws (2010), 119 descendants of its own
- K112583: Synthes Cortical Screws (2011), 118 descendants of its own
- K113014: Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws (2012), 97 descendants of its own

## Indications for use
The OrthoHelix Clavicle Plating System Plates are indicated for fixation of fractures, fusions and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle.

Source page: https://510kreport.com/device/K090289
Methodology: https://510kreport.com/methodology