510(k) · Cleared
ClearedCrossRoads Modular Tray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crossroads Extremity Systems · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Jul 16, 2024 as substantially equivalent to K202268 (Crossroads Extremity Systems, LLC, 2020) after a 90-day review. Its family tree reaches back 9 generations to 1984.
- Decided
- Jul 16, 2024
- Review
- 90 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K844002 (1984). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 5 generations between
- 3 generations backK180127 TCAT (R) THA Instrument Tray SetTHINK Surgical, Inc. · 2019
- 2 generations backK200632 TCAT TKA Instrument Tray SetTHINK Surgical, Inc. · 2020
- 1 generation backK202268 CrossRoads Tray SystemCrossroads Extremity Systems, LLC · 2020
- This deviceK241050 CrossRoads Modular Tray SystemCrossroads Extremity Systems · 2024
Show all 9 generations
- Root · 9 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 8 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 7 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 6 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 5 generations backK032119 Paragon Medical Surgical Instrument Delivery System VariousParagon Medical, Inc. · 2003
- 4 generations backK072211 Intuitive Surgical Instrument and Accessories Sterilization TraysIntuitive Surgical, Inc. · 2008
- 3 generations backK180127 TCAT (R) THA Instrument Tray SetTHINK Surgical, Inc. · 2019
- 2 generations backK200632 TCAT TKA Instrument Tray SetTHINK Surgical, Inc. · 2020
- 1 generation backK202268 CrossRoads Tray SystemCrossroads Extremity Systems, LLC · 2020
- This deviceK241050 CrossRoads Modular Tray SystemCrossroads Extremity Systems · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −8 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −7 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −6 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −5 | K032119 | Paragon Medical Surgical Instrument Delivery System Various | Paragon Medical, Inc. | 2003 | — |
| −4 | K072211 | Intuitive Surgical Instrument and Accessories Sterilization Trays | Intuitive Surgical, Inc. | 2008 | — |
| −3 | K180127 | TCAT (R) THA Instrument Tray Set | THINK Surgical, Inc. | 2019 | — |
| −2 | K200632 | TCAT TKA Instrument Tray Set | THINK Surgical, Inc. | 2020 | — |
| −1 | K202268 | CrossRoads Tray System | Crossroads Extremity Systems, LLC | 2020 | — |
| 0 (this device) | K241050 | CrossRoads Modular Tray System | Crossroads Extremity Systems | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 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 KCT? 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 KCT device
- #1 K214041 Aesculap AICON Containerscore 18.1 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K202268 | CrossRoads Tray SystemSummary page 5…terilization Wrap Containers, Trays, Cassettes & Other Accessories Regulation Number: 21 CFR 880.6850 Product Code: KCT Legally Marketed Predicate Device Predicate #: K202268 Predicate Trade Name: CrossRoads Tray System Product Code: KCT Device Description Summary The CrossRoads Modular Tray System i… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 40 years and passes through 9 companies; a new generation was cleared every 3.1 years on median.
- None of the 13 ancestors has a recall.
- 1 other device also cites its predicate K202268.
How does its category compare?
All KCT devicesKCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · KCT
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KCT
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KCT
17in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KCT
50in 2025
MAUDE reports naming product code KCT, 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 | 3 | 199 | 0 | 2 |
| 2008 | 6 | 182 | 0 | 8 |
| 2009 | 6 | 89 | 0 | 5 |
| 2010 | 12 | 202 | 1 | 3 |
| 2011 | 6 | 117 | 2 | 3 |
| 2012 | 10 | 236 | 0 | 2 |
| 2013 | 8 | 131 | 1 | 6 |
| 2014 | 11 | 169 | 1 | 5 |
| 2015 | 15 | 151 | 0 | 6 |
| 2016 | 12 | 182 | 3 | 16 |
| 2017 | 10 | 211 | 1 | 3 |
| 2018 | 15 | 192 | 0 | 22 |
| 2019 | 18 | 187 | 0 | 15 |
| 2020 | 14 | 134 | 0 | 66 |
| 2021 | 18 | 185 | 1 | 26 |
| 2022 | 11 | 137 | 17 | 8 |
| 2023 | 10 | 94 | 0 | 30 |
| 2024 | 8 | 106 | 0 | 18 |
| 2025 | 11 | 205 | 0 | 50 |
| 2026 | 9 | 122 | 0 | — |
What is it indicated for?
The CrossRoads Modular Tray System is used in healthcare facilities to store and organize CrossRoads surgical instruments and components during sterilization and during implant/prosthetic treatment. The CrossRoads Modular Tray System is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. Sterilization validations for the worst-case CrossRoads Modular…
Read the full statement (127 words)
The CrossRoads Modular Tray System is used in healthcare facilities to store and organize CrossRoads surgical instruments and components during sterilization and during implant/prosthetic treatment. The CrossRoads Modular Tray System is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. Sterilization validations for the worst-case CrossRoads Modular Tray System included surgical instruments such as inserters, reamers, fixation pin, benders, and ratcheting handles. The CrossRoads Modular Tray System is validated for a maximum load of 18.7 lbs (tray + instruments).
Method: Steam Sterilization (Moist Heat Sterilization) Cycle Pre-vacuum
Temperature: 270 °F (132 °C)
Exposure time: 4 minutes
Drying time: 20 minutes
Dimensions do not exceed:
20.546" length x 10.022" width x 3.978" depth
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241050 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241050: CrossRoads Modular Tray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241050
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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