Cleared Traditional

K172130 - Resorbable Mesh Device

K172130 is the FDA 510(k) clearance for Resorbable Mesh Device by SeaSpine Orthopedics Corporation. It is a Class 2 Orthopedic device (product code MQV) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K172130 · SeaSpine Orthopedics Corporation · Orthopedic device
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Nov 2017
Decision
125d
Days
Class 2
Risk

K172130 is an FDA 510(k) clearance for the Resorbable Mesh Device. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by SeaSpine Orthopedics Corporation (Irvine, US). The FDA issued a Cleared decision on November 16, 2017 after a review of 125 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 SeaSpine Orthopedics Corporation devices

Submission Details

510(k) Number K172130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2017
Decision Date November 16, 2017
Days to Decision 125 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
3d slower than avg
Panel avg: 122d · This submission: 125d
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 232
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K172130.
ABCcolla Bone Graft
K171629 · Acro Biomedical Co., Ltd. · Feb 2018
BioSphere MIS Putty (BioSphere MIS)
K173301 · Synergy Biomedical, LLC · Jan 2018
NuVasive AttraX Scaffold
K172497 · Nu Vasive, Incorporated · Nov 2017
MASTERGRAFT Contain
K151172 · Medtronic Sofamor Danek USA, Inc. · Aug 2015
MASTERGRAFT MATRIX EXT
K141824 · Medtronic Sofamor Danek, Inc. · Sep 2014
CONFIRM BIOACTIVE
K133678 · Globus Medical, Inc. · Aug 2014