# K080111: Arthrex Compression Staple

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Feb 13, 2008 after 28 days
- Product code: JDR (Staple, 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: 1 generation back to K043059 (2005). 1 ancestor in all.
9 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043059: Compression Staple and Simple Staple, Wrightmedicaltechnologyinc (2005) Summary page 1.

## Most influential descendants
- K130510: Arthrex Compression Plates (2013), 8 descendants of its own
- 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

## Indications for use
The Arthrex Compression Staple is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition, and stabilize metatarsus primus varus.

Source page: https://510kreport.com/device/K080111
Methodology: https://510kreport.com/methodology