# K233025: Revolution External Plating System

- Pathway: 510(k) (Traditional)
- Applicant: New Standard Device Dba Metalogix
- Decided: May 30, 2024 after 251 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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: 14 generations back to K962616 (1996). 67 ancestors in all.
No later device cites it as a predicate yet.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181630: Revolution External Plating System, New Standard Device Dba Metalogix (2019) Summary page 5.

## Indications for use
The Revolution External Plating System is indicated for treatment of a variety of broken or deformed bones: • Stabilizes open and/or unstable fracture of complex proximal and/or distal tibial fractures • Fusions of the joints and bone (hand, foot, long-bone) • Correction of bone or soft tissue deformities • Correction of segmental or non-segmental bone, soft tissue defects or bone loss • Neutralization of fractures stabilized with limited internal fixation • Adult and Pediatric subgroups except newborns

Source page: https://510kreport.com/device/K233025
Methodology: https://510kreport.com/methodology