# K181630: Revolution External Plating System

- Pathway: 510(k) (Traditional)
- Applicant: New Standard Device Dba Metalogix
- Decided: May 29, 2019 after 343 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K962616 (1996). 66 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071394: Modification to:Sbi Ringfix, Small Bone Innovations, Inc. (2007) Summary page 5.
- K053472: Hoffmann II Mri External Fixation System, Howmedica Osteonics Corp. (2006) Summary page 5.
- K152171: Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4, Orthofix Srl (2015) Summary page 5.
- K970748: Taylor Spatial Frame External Fixation System, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 5.
- K112218: Ace-Fischer (R), Tempfix (R), Hoffman Classic (TM) External Fixators, DePuy Orthopaedics, Inc. (2011) Summary page 5.
- K031181: External Fixation Systems, Smith & Nephew, Inc. (2003) Summary page 5.
- K140463: Integra External Fixation System, Ascension Orthopedic (2014) Summary page 5.

## Most influential descendants
- K233025: Revolution External Plating System (2024), 0 descendants of its own

## Recalls of this device
- Dec 28, 2020 · Class II · Z-1649-2022: Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
- Jun 8, 2020 · Class II · Z-1236-2022: 1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The increased wire diameter and new manufacturing process are meant to provide a stronger wire and reduced brea
- Oct 10, 2019 · Class II · Z-0318-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Aug 14, 2019 · Class II · Z-1280-2022: Due to manufacturing processing error, wrench causing stripping when torqueing nuts.
- Jul 23, 2019 · Class II · Z-1824-2023: The threads on posts stripping out when tensioned during application process.

## 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/K181630
Methodology: https://510kreport.com/methodology