# K132594: Crosscheck Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Solana Surgical, LLC
- Decided: Dec 13, 2013 after 116 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 21 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K000684 (2000). 13 ancestors in all.
23 later devices descend from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083447: Memometal Anchorage Bone Plate System, Models PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50, Memometal Technologies (2009) Summary page 1.
- K123000: Integra Total Foot Systems, Integra LifeSciences Corporation (2012) Summary page 1.

## Most influential descendants
- K152974: ORTHOLOC® 3Di Foot Plating Reconstruction System (2015), 22 descendants of its own
- K203817: Tyber Medical Anatomical Plating System (2021), 10 descendants of its own
- K222465: Tyber Medical Anatomical Plating System (2023), 9 descendants of its own
- K232652: Anatomical Plating System (various) (2023), 3 descendants of its own
- K241218: Tyber Medical Anatomical Plating System (2024), 2 descendants of its own

## Recalls of this device
- Jul 21, 2015 · Class II · Z-2541-2015: These screws have a potential of passing through the plate in the case when torque is applied in excessive amounts, which may result in intraoperative malfunction.
- Jul 21, 2015 · Class II · Z-2542-2015: These screws have a potential of passing through the plate in the case when torque is applied in excessive amounts, which may result in intraoperative malfunction.
- Mar 6, 2015 · Class II · Z-1494-2015: The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
- Mar 6, 2015 · Class II · Z-1488-2015: The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
- Mar 6, 2015 · Class II · Z-1484-2015: The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
- Mar 6, 2015 · Class II · Z-1500-2015: The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction.
- Mar 6, 2015 · Class II · Z-1498-2015: The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
- Mar 6, 2015 · Class II · Z-1482-2015: The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction.
- Mar 6, 2015 · Class II · Z-1496-2015: The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
- Mar 6, 2015 · Class II · Z-1483-2015: The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction.
- Mar 6, 2015 · Class II · Z-1495-2015: The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
- Mar 6, 2015 · Class II · Z-1486-2015: The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
- Mar 6, 2015 · Class II · Z-1493-2015: The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
- Mar 6, 2015 · Class II · Z-1487-2015: The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
- Mar 6, 2015 · Class II · Z-1485-2015: The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
- Mar 6, 2015 · Class II · Z-1491-2015: The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
- Mar 6, 2015 · Class II · Z-1489-2015: The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
- Mar 6, 2015 · Class II · Z-1490-2015: The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
- Mar 6, 2015 · Class II · Z-1492-2015: The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
- Mar 6, 2015 · Class II · Z-1499-2015: The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction.
- Mar 6, 2015 · Class II · Z-1497-2015: The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction

## Indications for use
The Solana Surgical LLC, CrossCheck Plating System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones in the hand, feet, wrist, and ankles, fingers and toes. The system may be used in both pediatric and adult patients. The device is intended for single use.

Source page: https://510kreport.com/device/K132594
Methodology: https://510kreport.com/methodology