# K071477: Reverto 55 and 37 Shape Memory Staples

- Pathway: 510(k) (Traditional)
- Applicant: Core Essence Orthopaedics, LLC
- Decided: Aug 15, 2007 after 78 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 K902307 (1990). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993714: Memograph Staple, Warm System, Biomedical Ent., Inc. (2000) Summary page 2.
- K001354: Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for the Memograph Staple System, Biomedical Ent., Inc. (2001)
- K051408: Intelifuse, Inc. Warm System with Stimulinks, Intelifuse, Inc. (2005) Summary page 2.
- K060014: Intelifuse, Inc., Warmsystem with Stimulinks, Intelifuse, Inc. (2006) Summary page 2.
- K002695: Memodyn Staple, Telos Medical Equipment (2001) Summary page 2.

## Most influential descendants
- K141550: Instafix Shape Memory Fixation System (2014), 0 descendants of its own

## Indications for use
re VERTO TM Shape Memory Staples are 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 reVERTO TM Shape Memory Staples are 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/K071477
Methodology: https://510kreport.com/methodology