Cleared Traditional

K172130 - Resorbable Mesh Device

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

K172130 · SeaSpine Orthopedics Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K172130

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.

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 403
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K172130.
SCS 17-01
K173008 · Anika Therapeutics, Inc. · Dec 2017
ReBOSSIS85
K172573 · Orthorebirth Co., Ltd. · Dec 2017
NuVasive AttraX Scaffold
K172497 · Nu Vasive, Incorporated · Nov 2017
Bi-Ostetic Bioactive Glass Foam
K170917 · Berkeley Advanced Biomaterials · Oct 2017
Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)
K171161 · Dimensional Bioceramics, LLC · Sep 2017
MagnetOs Putty
K171563 · Kuros Biosciences B.V · Aug 2017