510(k) · Cleared
Recalled · Class II · 2015Crosscheck Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solana Surgical, LLC · HRS Plate, Fixation, Bone
Cleared on Dec 13, 2013 as substantially equivalent to K083447 (Memometal Technologies, 2009) and 1 other predicate after a 116-day review. Its family tree reaches back 4 generations to 2000. 23 later devices descend from it. It has been recalled 21 times.
- Decided
- Dec 13, 2013
- Review
- 116 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 21
- Predicates
- 2
Its longest line of descent runs back 4 generations to K000684 (2000). 13 ancestors in all. 23 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 3 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 2 generations backK102282 The Varia Fibula Locked Plating System Line Extension Addition of…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2010
- 1 generation backK123000 Integra Total Foot SystemsIntegra LifeSciences Corporation · 2012
- This deviceK132594 Crosscheck Plating SystemSolana Surgical, LLC · 2013
- Descendant · cites it directly · 22 of its ownK152974 ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc · 2015
- Descendant · 2 generations on · 10 of its ownK203817 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021
- Descendant · 3 generations on · 9 of its ownK222465 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2023
- Descendant · 3 generations on · 3 of its ownK232652 Anatomical Plating System (various)Tyber Medical, LLC · 2023 · Recalled
- Descendant · 4 generations on · 2 of its ownK241218 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2024
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc · 2015 · cites it directly22descendants
- K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2021 · 2 generations on10descendants
- K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2023 · 3 generations on9descendants
- K232652Anatomical Plating System (various)Tyber Medical, LLC · 2023 · 3 generations on3descendants
- K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2024 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −3 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −2 | K102282 | The Varia Fibula Locked Plating System Line Extension Addition of Straight… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2010 | — |
| −1 | K123000 | Integra Total Foot Systems | Integra LifeSciences Corporation | 2012 | — |
| 0 (this device) | K132594 | Crosscheck Plating System | Solana Surgical, LLC | 2013 | — |
| +1 | K152974 | ORTHOLOC® 3Di Foot Plating Reconstruction System | Wrightmedicaltechnologyinc | 2015 | — |
| +2 | K203817 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2021 | — |
| +3 | K222465 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2023 | — |
| +3 | K232652 | Anatomical Plating System (various) | Tyber Medical, LLC | 2023 | 20 |
| +4 | K241218 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 6 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HRS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083447 | Memometal Anchorage Bone Plate System, Models PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50Summary page 1…HRS Predicate Device(s): Memometal Anchorage Bone Plate System: K083447 Integra Total Foot System K 12300… | 2009 |
| * | K123000 | Integra Total Foot SystemsSummary page 1…System: K083447 Integra Total Foot System K 123000 Device Description: The Solana Surgical, LLC CrossCHECK Plating System consists of a variety of bone plates and screws to be u… | 2012 |
What descends from it? (23)
See all 231 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152974 | ORTHOLOC® 3Di Foot Plating Reconstruction System | 2015 | 22 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 21, 2015 | Class II | Z-2541-2015 | Employee error | 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 | Employee error | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | 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 | Nonconforming Material/Component | The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction |
The 5 latest of 21 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K152974 (Wrightmedicaltechnologyinc, 2015) has gone furthest, with 22 descendants of its own.
- 9 other devices also cite its predicate K083447.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132594 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132594: Crosscheck Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132594
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026