510(k) · Cleared
ClearedSynthes Graphic Case & Tray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes GmbH · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Mar 28, 2025 as substantially equivalent to K202268 (Crossroads Extremity Systems, LLC, 2020) after a 270-day review. Its family tree reaches back 9 generations to 1984. 1 later device descends from it.
- Decided
- Mar 28, 2025
- Review
- 270 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. 1 later device descends from it, 1 citing it directly.
- 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 deviceK241927 Synthes Graphic Case & Tray SystemSynthes GmbH · 2025
- Descendant · cites it directly · 0 of its ownK253791 PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect…DePuy Mitek, Inc. · 2026
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 deviceK241927 Synthes Graphic Case & Tray SystemSynthes GmbH · 2025
Most influential descendants
Showing 1 of 1 · See all- K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc. · 2026 · cites it directly0descendants
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) | K241927 | Synthes Graphic Case & Tray System | Synthes GmbH | 2025 | — |
| +1 | K253791 | PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula… | DePuy Mitek, Inc. | 2026 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 6…Classification Regulation Number: 21 CFR 880.6850 Product Code: KCT Predicate / Predicate Device: CrossRoads Tray System (K202268) Reference Reference Device: DePuy Synthes Sterilization Container System (K181933) devices… | 2020 |
| † | K181933 | DePuy Synthes Sterilization Container System | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253791 | PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid | 2026 | 0 |
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 41 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.
- Of its descendants, K253791 (DePuy Mitek, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 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. 2025, 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 Synthes Graphic Case & Tray System are used in healthcare facilities to store, organize, and transport DePuy Synthes orthopedic instruments and implants during sterilization and surgical procedures. The Synthes Graphic Case & Tray System are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterile barrier (e.g., wraps or reusable rigid sterilization containers). The…
Read the full statement (168 words)
The Synthes Graphic Case & Tray System are used in healthcare facilities to store, organize, and transport DePuy Synthes orthopedic instruments and implants during sterilization and surgical procedures. The Synthes Graphic Case & Tray System are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterile barrier (e.g., wraps or reusable rigid sterilization containers).
The Synthes Graphic Case & Tray System is validated for use with orthopedic medical devices including lumen (cannulated) devices and mated surface devices (devices or device configurations with conjoined surfaces which meet, touch or unite). Compatible instrument and implant materials include intrinsically stable metals, composites, thermoplastics and thermosetting polymers with constant use temperatures above 135°C.
The Synthes Graphic Case & Tray System were validated for a maximum load of 25 Ibs (case + contents+ lid+ weight of sterile barrier wrap).
Method: Steam Sterilization (Moist Heat Sterilization) Cycle Pre-vacuum
Temperature: 270 °F (132 °C)
Exposure time: 4 minutes
Minimum Drying time: 20 minutes
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K241927 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241927: Synthes Graphic Case & 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/K241927
Report an extraction error
Are you the manufacturer?
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