# K201132: Arthrex Compression Screws

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jul 27, 2020 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: 12 generations back to K000684 (2000). 94 ancestors in all.
11 later devices descend from it; 8 cite it directly.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103705: Low Profile Screws, Arthrex, Inc. (2011) Summary page 5.
- K111253: Arthrex Distal Extremity Plate System, Arthrex, Inc. (2011) Summary page 5.
- K131474: Arthrex Distal Radius Plate System, Arthrex, Inc. (2013) Summary page 5.
- K141735: Arthrex Ankle Fusion Plating System, Arthrex, Inc. (2014) Summary page 5.
- K151732: Arthrex Fracture Plates, Arthrex, Inc. (2015) Summary page 5.
- K170547: Arthrex Mesh Plate System, Arthrex, Inc. (2017) Summary page 5.

## Most influential descendants
- K254215: Arthrex Beaming System (2026), 1 descendant of its own
- K250920: Arthrex Spine Compression FT Screw (2025), 1 descendant of its own
- K243195: Arthrex SS VAL and VAL KreuLock™ Compression Screw System (2025), 1 descendant of its own
- K242554: Arthrex VAL and VAL KreuLock™ Compression Screw System (2024), 1 descendant of its own
- K241592: Arthrex VAL and VAL KreuLock™ Compression Screw System (2024), 1 descendant of its own

## Indications for use
The Arthrex KreuLock Compression Screws (2.0-3.0 mm solid) are intended to be used in a plate-screw system for internal bone 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 Plate, Small Fragment Plates, Distal Extremity Plates, Mesh Plates (2.7-3.0) and Distal Radius Plates. The Arthrex KreuLock Compression Screws (3.5 mm and larger, solid) are intended to be used 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, calcaneus, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates. The Arthrex Compression FT Screws (2.0-3.0 mm cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. The Arthrex Compression FT Screws (3.5 mm and larger, cannulated) are intended to be used as stand-alone bone screws 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, calcaneus, femur and fibula.

Source page: https://510kreport.com/device/K201132
Methodology: https://510kreport.com/methodology