# K203468: TCAT TKA Instrument Tray

- Pathway: 510(k) (Traditional)
- Applicant: THINK Surgical, Inc.
- Decided: Dec 20, 2021 after 390 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: 8 generations back to K844002 (1984). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200632: TCAT TKA Instrument Tray Set, THINK Surgical, Inc. (2020) Summary page 5.

## Indications for use
The THINK Surgical TCAT® TKA Instrument Tray is intended to protect, organize and deliver to the surgical field TCAT® tools, instruments and accessories. The tray allows sterilization of TCAT® tools, instruments and accessories and maintains sterility of the enclosed devices until used. The tray is wrapped with an FDA-cleared sterilization wrap during the pre-vacuum autoclave sterilization process.

Source page: https://510kreport.com/device/K203468
Methodology: https://510kreport.com/methodology