# K130510: Arthrex Compression Plates

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Sep 25, 2013 after 210 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: 6 generations back to K000684 (2000). 16 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 25 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.
- K040907: Arthrex Small Fragment Plates and Screws, Arthrex, Inc. (2004) Summary page 1.
- K080111: Arthrex Compression Staple, Arthrex, Inc. (2008). Our reading of the summary gave K080011, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Arthrex Compression Staple”.

## Most influential descendants
- K150456: Arthrex Plates, Screws, and Staples (2015), 6 descendants of its own
- K250920: Arthrex Spine Compression FT Screw (2025), 1 descendant of its own
- K222267: Arthrex 2.4 mm Volar Distal Radius Plate System (2022), 1 descendant of its own
- K262618: Arthrex Spine Compression FT Screw (2026), 0 descendants of its own
- K252807: Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates (2026), 0 descendants of its own

## Indications for use
The Arthrex Compression Plates are intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle, foot, hand, and wrist, such as opening wedge osteotomies of Hallux Valgus.

Source page: https://510kreport.com/device/K130510
Methodology: https://510kreport.com/methodology
