# K052614: Low Profile Plate and Screw System

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Sep 28, 2005 after 5 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: 5 generations back to K000684 (2000). 13 ancestors in all.
245 later devices descend from it; 13 cite it directly.
0 of 259 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040907: Arthrex Small Fragment Plates and Screws, Arthrex, Inc. (2004) Summary page 1.

## Most influential descendants
- K103705: Low Profile Screws (2011), 219 descendants of its own
- K111253: Arthrex Distal Extremity Plate System (2011), 135 descendants of its own
- K112437: Arthrex Fracture System (2011), 91 descendants of its own
- K123241: Arthrex Fracture Plates (2013), 71 descendants of its own
- K111678: Ortho Solutions Extremity Fixation Implants for Osteosysnthesis (2012), 58 descendants of its own

## Indications for use
The Arthrex Low Profile Plate and Screw System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle, foot, hand, and wrist, such as opening wedge osteotomies of Hallux Valgus.

Source page: https://510kreport.com/device/K052614
Methodology: https://510kreport.com/methodology