# K112437: Arthrex Fracture System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Dec 21, 2011 after 119 days
- Product code: HTN (Washer, Bolt Nut)
- 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: 8 generations back to K000684 (2000). 72 ancestors in all.
91 later devices descend from it; 6 cite it directly.
0 of 164 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001)
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS, Arthrex, Inc. (2005) Summary page 1.
- K052776: Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD, Arthrex, Inc. (2005) Summary page 1.
- K103705: Low Profile Screws, Arthrex, Inc. (2011) Summary page 2.
- K111253: Arthrex Distal Extremity Plate System, Arthrex, Inc. (2011)

## Cited in the summary but kept off the family tree
- K102998: Congruent Bone Plate  System, Acumed, LLC (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K123241: Arthrex Fracture Plates (2013), 71 descendants of its own
- K141735: Arthrex Ankle Fusion Plating System (2014), 38 descendants of its own
- K141478: Arthrex Fracture Plates and Screws (2014), 23 descendants of its own
- K151732: Arthrex Fracture Plates (2015), 21 descendants of its own
- K170518: In2Bones Fracture and Correction System (2017), 15 descendants of its own

## Indications for use
The Arthrex Fracture Syvstem is intended to be used for internal bone fixation for bone fraictures, fusions, osteotomies and non-unions in the ankle, foot hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. The Arthrex Fracture Plates are to be used with the 2.7mm-4.Omm Arthrex Low Profile Screws. The Clavicle Plate Button is intended for use with the clavicle plates for clavicle indications such as for th& treatment of syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruption, and this button may not be used alone. The button is intended to be used with #5 FiberWire or FiberTape.

Source page: https://510kreport.com/device/K112437
Methodology: https://510kreport.com/methodology