Cleared Traditional

K170620 - ReBOSSIS85

K170620 is an FDA 510(k) clearance for ReBOSSIS85, manufactured by Orthorebirth Co., Ltd.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K170620 · Orthorebirth Co., Ltd. · Orthopedic device
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Jun 2017
Decision
114d
Days
Class 2
Risk

K170620 is an FDA 510(k) clearance for the ReBOSSIS85. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Orthorebirth Co., Ltd. (Yokohama, JP). The FDA issued a Cleared decision on June 23, 2017 after a review of 114 days - within the typical 510(k) review window.

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: 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 Orthorebirth Co., Ltd. devices

FDA 510(k) Submission Details - K170620

510(k) Number K170620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2017
Decision Date June 23, 2017
Days to Decision 114 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
8d faster than avg
Panel avg: 122d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQV Device Classification - Class 2, Special Controls

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 293
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K170620.
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NovaBone IRM
K163310 · Novabone Products, LLC · Jan 2017
HydroSet XT
K161447 · Orthovita, Inc. · Oct 2016