Cleared Traditional

K031319 - OSTEO-G BONE VOID FILLER SYSTEM

K031319 is an FDA 510(k) clearance for OSTEO-G BONE VOID FILLER SYSTEM, manufactured by Aspine USA, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K031319 · Aspine USA, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
83d
Days
Class 2
Risk

K031319 is an FDA 510(k) clearance for the OSTEO-G BONE VOID FILLER SYSTEM. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Aspine USA, Inc. (San Diego, US). The FDA issued a Cleared decision on July 17, 2003 after a review of 83 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K031319

510(k) Number K031319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2003
Decision Date July 17, 2003
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
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 492
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K031319.
BONESOURCE BVF
K031435 · Howmedica Osteonics · Aug 2003
THERIFIL BONE FILLER
K031040 · Therics, Inc. · Jul 2003
POLYGRAFT BONE GRAFT SUBSTITUTE
K030288 · Osteobiologics, Inc. · Jul 2003
CELLPLEX TCP SYNTHETIC CANCELLOUS BONE
K031817 · Wrightmedicaltechnologyinc · Jul 2003
OSSATURA BCP BONE VOID FILLER
K030131 · Isotis NV · May 2003
CALLOS
K030554 · Skeletal Kinetics, LLC · May 2003
K031319 · OSTEO-G BONE VOID FILLER SYSTEM
Download PDF FDA Summary Aspine USA, Inc.