510(k) · Cleared
ClearedTCAT TKA Instrument Tray Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
THINK Surgical, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Apr 8, 2020 as substantially equivalent to K180127 (THINK Surgical, Inc., 2019) after a 29-day review. Its family tree reaches back 7 generations to 1984. 5 later devices descend from it.
- Decided
- Apr 8, 2020
- Review
- 29 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K844002 (1984). 11 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 6 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 5 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 4 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 3 generations backK032119 Paragon Medical Surgical Instrument Delivery System VariousParagon Medical, Inc. · 2003
- 2 generations backK072211 Intuitive Surgical Instrument and Accessories Sterilization TraysIntuitive Surgical, Inc. · 2008
- 1 generation backK180127 TCAT (R) THA Instrument Tray SetTHINK Surgical, Inc. · 2019
- This deviceK200632 TCAT TKA Instrument Tray SetTHINK Surgical, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK202268 CrossRoads Tray SystemCrossroads Extremity Systems, LLC · 2020
- Descendant · 2 generations on · 1 of its ownK241927 Synthes Graphic Case & Tray SystemSynthes GmbH · 2025
- Descendant · 3 generations on · 0 of its ownK253791 PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect…DePuy Mitek, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK241050 CrossRoads Modular Tray SystemCrossroads Extremity Systems · 2024
- Descendant · cites it directly · 0 of its ownK203468 TCAT TKA Instrument TrayTHINK Surgical, Inc. · 2021
Most influential descendants
Showing 5 of 5 · See all- K202268CrossRoads Tray SystemCrossroads Extremity Systems, LLC · 2020 · cites it directly3descendants
- K241927Synthes Graphic Case & Tray SystemSynthes GmbH · 2025 · 2 generations on1descendant
- K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc. · 2026 · 3 generations on0descendants
- K241050CrossRoads Modular Tray SystemCrossroads Extremity Systems · 2024 · 2 generations on0descendants
- K203468TCAT TKA Instrument TrayTHINK Surgical, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −6 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −5 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −4 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −3 | K032119 | Paragon Medical Surgical Instrument Delivery System Various | Paragon Medical, Inc. | 2003 | — |
| −2 | K072211 | Intuitive Surgical Instrument and Accessories Sterilization Trays | Intuitive Surgical, Inc. | 2008 | — |
| −1 | K180127 | TCAT (R) THA Instrument Tray Set | THINK Surgical, Inc. | 2019 | — |
| 0 (this device) | K200632 | TCAT TKA Instrument Tray Set | THINK Surgical, Inc. | 2020 | — |
| +1 | K202268 | CrossRoads Tray System | Crossroads Extremity Systems, LLC | 2020 | — |
| +2 | K241927 | Synthes Graphic Case & Tray System | Synthes GmbH | 2025 | — |
| +3 | K253791 | PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula… | DePuy Mitek, Inc. | 2026 | — |
| +2 | K241050 | CrossRoads Modular Tray System | Crossroads Extremity Systems | 2024 | — |
| +1 | K203468 | TCAT TKA Instrument Tray | THINK Surgical, Inc. | 2021 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K180127 | TCAT (R) THA Instrument Tray SetSummary page 5…Wrap Regulation number: 21 CFR 880.6850 Classification Code: KCT Predicate Device: TCAT® THA Instrument Tray Set cleared via K180127. Device Modification: The changes to the predicated device allow tools, instruments and accessories to be utilized during a tota… | 2019 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 36 years and passes through 7 companies; a new generation was cleared every 3.1 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K202268 (Crossroads Extremity Systems, LLC, 2020) has gone furthest, with 3 descendants of its own.
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. 2020, 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 THINK Surgical TCAT® TKA Instrument Tray Set is intended to protect, organize, and deliver to the surgical field TCAT® tools, instruments and accessories. The trays allow sterilization of tools, instruments and accessories, and maintain sterility of the enclosed devices until used. The trays are wrapped with an FDA-cleared sterilization wrap during the pre-vacuum autoclave sterilization process.
[See the following page for the THINK Surgical compatible devices, sterilization parameters and description of the TCAT® TKA Instrument Tray Set.]
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200632 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200632: TCAT TKA Instrument Tray Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200632
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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