# K201235: Arthrex MaxForce MTP Compression Plates and Screws

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jul 6, 2020 after 60 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: 8 generations back to K000684 (2000). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130510: Arthrex Compression Plates, Arthrex, Inc. (2013) Summary page 4.
- K111253: Arthrex Distal Extremity Plate System, Arthrex, Inc. (2011) Summary page 4.
- K103705: Low Profile Screws, Arthrex, Inc. (2011) Summary page 4.

## Indications for use
The Arthrex MaxForce MTP Compression Plates are intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the Forefoot. 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 screws may be used with the Arthrex Low Profile Plates, Small Fragment Plates and MaxForce MTP Compression Plates. 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 Plates, Small Fragment Plates, Humeral Fracture Plates, Osteotomy Plates, and MaxForce MTP Compression Plates.

Source page: https://510kreport.com/device/K201235
Methodology: https://510kreport.com/methodology