# K102387: Mediscope Compressiopn Staple and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Mediscope Manufacturing, Inc.
- Decided: Oct 24, 2011 after 427 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.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The Mediscope Asymmetrical 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 metatarsocuneiforni joint to reposition and stabilize metatarsus primus varus.

Source page: https://510kreport.com/device/K102387
Methodology: https://510kreport.com/methodology
