# K180127: TCAT (R) THA Instrument Tray Set

- Pathway: 510(k) (Traditional)
- Applicant: THINK Surgical, Inc.
- Decided: Mar 15, 2019 after 422 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: 6 generations back to K844002 (1984). 10 ancestors in all.
6 later devices descend from it; 1 cites 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)
- K072211: Intuitive Surgical Instrument and Accessories Sterilization Trays, Intuitive Surgical, Inc. (2008) Summary page 5.

## Most influential descendants
- K200632: TCAT TKA Instrument Tray Set (2020), 5 descendants of its own
- 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

## Indications for use
The THINK Surgical TCAT® THA 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.

Source page: https://510kreport.com/device/K180127
Methodology: https://510kreport.com/methodology