# K043059: Compression Staple and Simple Staple

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jan 18, 2005 after 74 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
No predicates in its family tree.
207 later devices descend from it; 10 cite it directly.
0 of 208 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K051908: Charlotte Compression Plate (2005), 149 descendants of its own
- K070447: Newdeal Compression Plate (2007), 102 descendants of its own
- K093914: Newdeal Compression Plates (2011), 98 descendants of its own
- K113014: Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws (2012), 97 descendants of its own
- K121651: Ortholoc 3DI Midfoot/Flatfoot System (2012), 95 descendants of its own

## Indications for use
The Compression Staple is intended to be used for fixation such as: LisFranc arthrodesis, 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. The Simple Staple is intended to be used for wedge osteotomy of the first phalanx (Akin osteotomy), in the treatment of hallux-valgus in order to correct a remaining valgus or pronation of the first ray, and external rotation, and wind-swept toes.

Source page: https://510kreport.com/device/K043059
Methodology: https://510kreport.com/methodology