Cleared Traditional

K191670 - CureOs TCP

K191670 is the FDA 510(k) clearance for CureOs TCP by Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic. It is a Class 2 Orthopedic device (product code MQV) cleared through the Traditional 510(k) pathway after a 410-day FDA review.

K191670 · Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic · Orthopedic device
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Aug 2020
Decision
410d
Days
Class 2
Risk

K191670 is an FDA 510(k) clearance for the CureOs TCP. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic (Ankara, TR). The FDA issued a Cleared decision on August 4, 2020 after a review of 410 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - 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: 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 Orthopedic submissions.

View all Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic devices

Submission Details

510(k) Number K191670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2019
Decision Date August 04, 2020
Days to Decision 410 days
Submission Type Traditional
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
288d slower than avg
Panel avg: 122d · This submission: 410d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQV Filler, Bone Void, Calcium Compound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3045
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 - MQV Filler, Bone Void, Calcium Compound

All 230
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K191670.
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K193075 · Sirakoss , Ltd. · Jun 2020