Cleared Traditional

K180127 - TCAT THA Instrument Tray Set

K180127 is the FDA 510(k) clearance for TCAT THA Instrument Tray Set by THINK Surgical, Inc.. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 422-day FDA review.

K180127 · THINK Surgical, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Mar 2019
Decision
422d
Days
Class 2
Risk

K180127 is an FDA 510(k) clearance for the TCAT (R) THA Instrument Tray Set. 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 March 15, 2019 after a review of 422 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all THINK Surgical, Inc. devices

Submission Details

510(k) Number K180127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2018
Decision Date March 15, 2019
Days to Decision 422 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
293d slower than avg
Panel avg: 129d · This submission: 422d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

Regulatory Consultant

Think Surgical, Incorporated
George J. Prendergast

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 161
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K180127.
DePuy Synthes Sterilization Container System
K181933 · Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · May 2019
Neodent Instruments Kits
K182865 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · May 2019
Stryker ChestShield Sterilization Tray System
K183701 · Paragon Medical · May 2019
PRO-LITE Sterilization Tray
K183402 · STERIS Corporation · Mar 2019
Omni Instrument Tray
K182052 · Hologic, Inc. · Feb 2019
Endoscope Sterilization Tray
K183139 · Intuitive Surgical, Inc. · Feb 2019