Cleared Special

Cartiva SCI instrumentation set (K192156) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K192156 · Cartiva, Inc. · Orthopedic device
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Sep 2019
Decision
26d
Days
Class 2
Risk

K192156 is an FDA 510(k) clearance for the Cartiva SCI instrumentation set. Classified as Instruments Designed For Press-fit Osteochondral Implants (product code QBO), Class II - Special Controls.

Submitted by Cartiva, Inc. (Alpharetta, US). The FDA issued a Cleared decision on September 4, 2019 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4505 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cartiva, Inc. devices

Submission Details

510(k) Number K192156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2019
Decision Date September 04, 2019
Days to Decision 26 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 122d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QBO Instruments Designed For Press-fit Osteochondral Implants
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.4505
Definition The Device Is Intended To Manipulate Bone And Cartilage Tissue Or Implant Materials For The Positioning, Alignment, Defect Creation, Or Placement Of Press-fit Osteochondral Implants.
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.