# K203239: Arthrex Low Profile Screws

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Dec 30, 2020 after 57 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: 11 generations back to K000684 (2000). 78 ancestors in all.
No later device cites it as a predicate yet.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112437: Arthrex Fracture System, Arthrex, Inc. (2011) Summary page 4.
- K141478: Arthrex Fracture Plates and Screws, Arthrex, Inc. (2014). Our reading of the summary gave K141487, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Arthrex Fracture Plates and Screws”.
- K143139: Arthrex Fracture System, Arthrex, Inc. (2015) Summary page 4.
- K143614: Arthrex Low Profile Screws, Arthrex, Inc. (2015) Summary page 4.

## Indications for use
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, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Humeral Fracture Plates, and Osteotomy Plates.

Source page: https://510kreport.com/device/K203239
Methodology: https://510kreport.com/methodology