# K111253: Arthrex Distal Extremity Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Aug 2, 2011 after 90 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). 32 ancestors in all.
135 later devices descend from it; 10 cite it directly.
0 of 168 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090692: Ortholoc 2.0/2.4 Plate System, Wrightmedicaltechnologyinc (2009) Summary page 1.
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 1.
- K050110: Synthes (Usa) LCP Modular Foot Plates, Synthes (Usa) (2005) Summary page 1.
- K103705: Low Profile Screws, Arthrex, Inc. (2011) Summary page 1.

## Most influential descendants
- K112437: Arthrex Fracture System (2011), 91 descendants of its own
- K123241: Arthrex Fracture Plates (2013), 71 descendants of its own
- K141735: Arthrex Ankle Fusion Plating System (2014), 38 descendants of its own
- K140397: Paralock Plating System / Tuffnek Screw (2014), 31 descendants of its own
- K141478: Arthrex Fracture Plates and Screws (2014), 23 descendants of its own

## Indications for use
The Arthrex Distal Extremity Plate System is intended for use in stabilization of fresh fractures, revision procedures, osteotomies, joint fusion and reconstruction of small bones and bone fragments of the hand/wrist, foot/ankle, and osteopenic bone.

Source page: https://510kreport.com/device/K111253
Methodology: https://510kreport.com/methodology