# K200632: TCAT TKA Instrument Tray Set

- Pathway: 510(k) (Special)
- Applicant: THINK Surgical, Inc.
- Decided: Apr 8, 2020 after 29 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K844002 (1984). 11 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180127: TCAT (R) THA Instrument Tray Set, THINK Surgical, Inc. (2019) Summary page 5.

## Most influential descendants
- K202268: CrossRoads Tray System (2020), 3 descendants of its own
- K241927: Synthes Graphic Case & Tray System (2025), 1 descendant of its own
- K253791: PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid (2026), 0 descendants of its own
- K241050: CrossRoads Modular Tray System (2024), 0 descendants of its own
- K203468: TCAT TKA Instrument Tray (2021), 0 descendants of its own

## Indications for use
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.]

Source page: https://510kreport.com/device/K200632
Methodology: https://510kreport.com/methodology