# K103705: Low Profile Screws

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Mar 18, 2011 after 88 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K000684 (2000). 28 ancestors in all.
219 later devices descend from it; 22 cite it directly.
0 of 248 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052614: Low Profile Plate and Screw System, Arthrex, Inc. (2005) Summary page 1.
- K062863: Osteomed Extended 2.0/2.4CANNULATED Screw System, Osteomed LP (2006) Summary page 1.
- K001941: Synthes Modular Foot System, Synthes (Usa) (2000) Summary page 1.
- K043185: Synthes 3.5MM Cortex Screws, Synthes (Usa) (2005) Summary page 1.
- K102343: Emerge Medical Cannulated Screw Fixation System, Emerge Medical (2010) Summary page 1.

## Most influential descendants
- 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
- K141735: Arthrex Ankle Fusion Plating System (2014), 38 descendants of its own

## Indications for use
The Arthrex Low Profile Screws (2.0-3.0mm 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, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile and Small Fragment Plates. The Arthrex Low Profile Screws (2.0-3.0mm 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 Low Profile Screws (3.5mm 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 and Small Fragment 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 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.

Source page: https://510kreport.com/device/K103705
Methodology: https://510kreport.com/methodology