Cleared Traditional

K130531 - ULTRAFUSE

K130531 is an FDA 510(k) clearance for ULTRAFUSE, manufactured by Baxter Healthcare Corp. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 403-day FDA review.

K130531 · Baxter Healthcare Corp · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
403d
Days
Class 2
Risk

K130531 is an FDA 510(k) clearance for the ULTRAFUSE. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Westlake Village, US). The FDA issued a Cleared decision on April 8, 2014 after a review of 403 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K130531

510(k) Number K130531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2013
Decision Date April 08, 2014
Days to Decision 403 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
281d slower than avg
Panel avg: 122d · This submission: 403d
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 431
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K130531.
SOLUM IV BONE VOID FILLER
K132470 · Spinesmith Partners, Llp · May 2014
OSTEOSPAN MORPHEUS
K132377 · Biogennix, LLC · May 2014
MASTERGRAFT PUTTY, MASTERGRAFT STRIP
K140375 · Medtronic Sofamor Danek USA, Inc. · Apr 2014
PRODENSE BONE GRAFT SUBSTITUTE
K132656 · Wrightmedicaltechnologyinc · Mar 2014
BG MORSELS
K132805 · Prosidyan, Inc. · Mar 2014
NB3D BONE VOID FILLER
K132050 · Pioneer Surgical Technology, Inc. · Feb 2014