# K141550: Instafix Shape Memory Fixation System

- Pathway: 510(k) (Special)
- Applicant: Ot Medical
- Decided: Jul 11, 2014 after 30 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071477: Reverto 55 and 37 Shape Memory Staples, Core Essence Orthopaedics, LLC (2007) Summary page 1.

## Indications for use
InstaFiXTM Shape Memory Fixation System is intended for use in: Fixation of Osteotomies of the Hand, Foot and Tibia Arthrodesis of the Joints of the Hand and Foot Fixation of Soft Tissue to Bone, as in the case of the Anterior Cruciate Ligament InstaFiXTM Shape Memory Fixation System is also indicated for adjunctive fixation of Small Bone Fragments of: The Upper Extremity, such as the Radius, Ulna, Humerus. Clavicle and Scapula The Lower Extremity, such as the Tibia, Fibula and the Femur The Upper Torso, such as the Sternum and the Ribs

Source page: https://510kreport.com/device/K141550
Methodology: https://510kreport.com/methodology