Cleared Traditional

K120356 - NCS FISH-FIT MD SYSTEM FISH-FIT MD COMP...

K120356 is an FDA 510(k) clearance for NCS FISH-FIT MD SYSTEM FISH-FIT MD COMP..., manufactured by Ncs Lab Srl. The device is a Class 2 Orthopedic device with product code MBI cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K120356 · Ncs Lab Srl · Orthopedic device
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Dec 2012
Decision
309d
Days
Class 2
Risk

K120356 is an FDA 510(k) clearance for the NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Ncs Lab Srl (Carpi, IT). The FDA issued a Cleared decision on December 11, 2012 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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. Elevated predicate reliance profile. 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 Ncs Lab Srl devices

FDA 510(k) Submission Details - K120356

510(k) Number K120356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2012
Decision Date December 11, 2012
Days to Decision 309 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
187d slower than avg
Panel avg: 122d · This submission: 309d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBI Device Classification - Class 2, Special Controls

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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.

Regulatory Peers - MBI Fastener, Fixation, Nondegradable, Soft Tissue

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