# K142148: Orthohelix Staple System

- Pathway: 510(k) (Special)
- Applicant: Orthohelix Surgical Designs, Inc.
- Decided: Aug 21, 2014 after 16 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: 4 generations back to K902307 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130832: Orthohelix Staple System, Orthohelix Surgical Designs, Inc. (2013) Summary page 4.
- K070031: Memometal Memory Staples, Memometal Technologies (2007) Summary page 4.
- K993714: Memograph Staple, Warm System, Biomedical Ent., Inc. (2000) Summary page 4.

## Indications for use
The OrthoHelix™ Staple System is indicated for fixation in the hand and foot including fractures, fusions, and osteotomies.

Source page: https://510kreport.com/device/K142148
Methodology: https://510kreport.com/methodology