# K070688: Nexfix Compression Staple

- Pathway: 510(k) (Traditional)
- Applicant: Nexa Orthopedics, Inc.
- Decided: May 18, 2007 after 67 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: 3 generations back to K964226 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 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.
- K011716: The Uni-Clip Staple, New Deal, S.A. (2001) Summary page 1.
- K060014: Intelifuse, Inc., Warmsystem with Stimulinks, Intelifuse, Inc. (2006) Summary page 1.

## Indications for use
The NexFixTM Compression Staple is indicated for fixation of fracture, fusion, and osteotomies of the hand, fore foot, mid foot and hind foot.

Source page: https://510kreport.com/device/K070688
Methodology: https://510kreport.com/methodology