TCAT (R) THA Instrument Tray Set
FDA 510(k) K180127 · THINK Surgical, Inc.
510(k) numberK180127
Submission
- Device name
- TCAT (R) THA Instrument Tray Set
- Applicant
- THINK Surgical, Inc.
Fremont, CA, US - Received
- January 17, 2018
- Decision date
- March 15, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6850
- Specialty
- General Hospital
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|---|---|---|---|
| K253988 | LiteSet TraysKCT · Traditional | Nobel Biocare AB | 09/08/2026SE |
| K261935 | Surgical and Prosthetic TraysKCT · Traditional | Dentsply Sirona, Inc. | 09/04/2026SE |
| K253187 | SteriBest® Sterilization Tray SystemKCT · Traditional | Mastel Surgical | 06/18/2026SE |
| K260726 | Straumann® ProClean Cassette (041.800 ; 041.801)KCT · Traditional | Institut Straumann AG | 06/03/2026SE |
| K252854 | SteriTite Container System with MediTray ProductsKCT · Traditional | Case Medical, Inc. | 06/03/2026SE |
| K253791 | PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System LidKCT · Traditional | DePuy Mitek, Inc. | 02/26/2026SE |
| K251614 | Stainless Steel Surgical KitsKCT · Traditional | Dentsply Sirona, Inc. | 02/06/2026SE |
| K251756 | Sterilization TraysKCT · Traditional | Paragon Implant Mfg., LLC | 11/14/2025SE |
| K251300 | Plastic Surgical KitsKCT · Traditional | Dentsply Sirona, Inc. | 07/22/2025SE |
| K243425 | Guided DAS Surgical KitKCT · Traditional | Talladium España, SL | 07/22/2025SE |
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| K261024 | TMINI Miniature Robotic SystemOLO · Traditional | 07/24/2026SE |
| K260010 | TMINI® Miniature Robotic SystemOLO · Traditional | 03/03/2026SE |
| K253661 | TMINI Miniature Robotic SystemOLO · Special | 12/22/2025SE |
| K252544 | TMINI Miniature Robotic SystemOLO · Traditional | 10/10/2025SE |
| K250877 | TMINI Miniature Robotic SystemOLO · Traditional | 06/20/2025SE |
| K243481 | TMINI Miniature Robotic SystemOLO · Traditional | 01/06/2025SE |
| K243285 | TMINI Miniature Robotic SystemOLO · Special | 11/15/2024SE |
| K242264 | TMINI Miniature Robotic SystemOLO · Special | 08/23/2024SE |
| K241031 | TMINI Miniature Robotic System (TMINI 1.1)OLO · Traditional | 07/12/2024SE |
| K232802 | TMINI Miniature Robotic SystemOLO · Special | 10/12/2023SE |
Questions and answers
When was TCAT (R) THA Instrument Tray Set cleared by the FDA?
TCAT (R) THA Instrument Tray Set (K180127) received a 510(k) decision of Substantially Equivalent on March 15, 2019, 422 days after the submission was received.
What is the product code of K180127?
The FDA product code is KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, a Class II (moderate risk) device regulated under 21 CFR 880.6850.