# K141478: Arthrex Fracture Plates and Screws

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Jul 8, 2014 after 34 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
Longest line of descent: 10 generations back to K000684 (2000). 75 ancestors in all.
23 later devices descend from it; 3 cite it directly.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123241: Arthrex Fracture Plates, Arthrex, Inc. (2013) Summary page 1.
- K103705: Low Profile Screws, Arthrex, Inc. (2011) Summary page 1.

## Most influential descendants
- K151732: Arthrex Fracture Plates (2015), 21 descendants of its own
- K201132: Arthrex Compression Screws (2020), 11 descendants of its own
- K171808: TDM Plate and Screw System (2018), 6 descendants of its own
- K242939: ARTFX Trauma Bone Plate and Screw System (2024), 2 descendants of its own
- K203294: Arthrex Pilon Fusion System (2021), 2 descendants of its own

## Recalls of this device
- Jun 24, 2020 · Class II · Z-2733-2020: Screws provided in packaging are 5mm shorter than intended

## Indications for use
The Arthrex Fracture Plates are intended to be used for internal bane fixation far bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, fibula. The Arthrex Low Profile Screws (2.0-2.4mm solid) are intended to be used as stand-alone bone screws, or in a plate screw system for internal bane fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile, Small Fragment Plates, and Distal Extremity Plates. The Arthrex Low Profile Screws (2.0-3.0mm cannulated) are intended to be used as stand-alone bone screws for internal bane fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, and wrist. The Arthrex Low Profile Screws (2.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Fracture Plates, distal Extremity Plates, Humeral Fracture Plates, and Osteotomy Plates. The Arthrex Low Profile Screws (3.5mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bane fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula.

Source page: https://510kreport.com/device/K141478
Methodology: https://510kreport.com/methodology