Cleared Traditional

K203468 - TCAT TKA Instrument Tray

K203468 is an FDA 510(k) clearance for TCAT TKA Instrument Tray, manufactured by THINK Surgical, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 390-day FDA review.

K203468 · THINK Surgical, Inc. · General Hospital
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Dec 2021
Decision
390d
Days
Class 2
Risk

K203468 is an FDA 510(k) clearance for the TCAT TKA Instrument Tray. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by THINK Surgical, Inc. (Fremont, US). The FDA issued a Cleared decision on December 20, 2021 after a review of 390 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all THINK Surgical, Inc. devices

FDA 510(k) Submission Details - K203468

510(k) Number K203468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2020
Decision Date December 20, 2021
Days to Decision 390 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
261d slower than avg
Panel avg: 129d · This submission: 390d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KCT Device Classification - Class 2, Special Controls

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

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All 230
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