Cleared Traditional

K140585 - CTC TCAT-TPLAN SURGICAL SYSTEM

K140585 is an FDA 510(k) clearance for CTC TCAT-TPLAN SURGICAL SYSTEM, manufactured by Curexo Technology Corporation. The device is a Class 2 Orthopedic device with product code OJP cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K140585 · Curexo Technology Corporation · Orthopedic device
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Aug 2014
Decision
164d
Days
Class 2
Risk

K140585 is an FDA 510(k) clearance for the CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM. Classified as Orthopedic Computer Controlled Surgical System (product code OJP), Class II - Special Controls.

Submitted by Curexo Technology Corporation (Melrose, US). The FDA issued a Cleared decision on August 18, 2014 after a review of 164 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - the FDA orthopedic device regulatory 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Curexo Technology Corporation devices

FDA 510(k) Submission Details - K140585

510(k) Number K140585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2014
Decision Date August 18, 2014
Days to Decision 164 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 122d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OJP Device Classification - Class 2, Special Controls

Product Code OJP Orthopedic Computer Controlled Surgical System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Pre-operative Planning And Intra-operative Execution Of Surgical Movements With Robotically Controlled End Effectors Under User Supervision. Alternative To Manual Planning And Broaching/reaming Techniques For Femoral Canal Preparation In Primary Total Hip Arthroplasty (tha).
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 Orthopedic devices follow this clearance model.