Cleared Traditional

K130977 - SIGNIFY BIOACTIVE

K130977 is an FDA 510(k) clearance for SIGNIFY BIOACTIVE, manufactured by Globus Medical, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K130977 · Globus Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
259d
Days
Class 2
Risk

K130977 is an FDA 510(k) clearance for the SIGNIFY BIOACTIVE. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on December 24, 2013 after a review of 259 days - an extended review cycle.

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 Globus Medical, Inc. devices

FDA 510(k) Submission Details - K130977

510(k) Number K130977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2013
Decision Date December 24, 2013
Days to Decision 259 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
137d slower than avg
Panel avg: 122d · This submission: 259d
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 432
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K130977.
BG MORSELS
K132805 · Prosidyan, Inc. · Mar 2014
NB3D BONE VOID FILLER
K132050 · Pioneer Surgical Technology, Inc. · Feb 2014
BIOACTIVE BONE GRAFT PUTTY
K132071 · Biostructures, LLC · Jan 2014
MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT
K131673 · Medtronic Sofamor Danek USA, Inc. · Oct 2013
KINEX BIOACTIVE
K130392 · Globus Medical, Inc. · Aug 2013
VIVORTE BVF LITE
K131133 · Vivorte, Inc. · Aug 2013