Cleared Traditional

K083449 - E-MATRIX GRAFT BONE EXTENDER

K083449 is an FDA 510(k) clearance for E-MATRIX GRAFT BONE EXTENDER, manufactured by Pioneer Surgical Technology. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K083449 · Pioneer Surgical Technology · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
203d
Days
Class 2
Risk

K083449 is an FDA 510(k) clearance for the E-MATRIX GRAFT BONE EXTENDER. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Pioneer Surgical Technology (Marquette, US). The FDA issued a Cleared decision on June 12, 2009 after a review of 203 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 Pioneer Surgical Technology devices

FDA 510(k) Submission Details - K083449

510(k) Number K083449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2008
Decision Date June 12, 2009
Days to Decision 203 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
81d slower than avg
Panel avg: 122d · This submission: 203d
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 442
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K083449.
DBX DEMINERALIZED BONE MATRIX PUTTY
K091218 · Musculoskeletal Transplant Foundation · Sep 2009
EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE
K090855 · Etex Corp. · Sep 2009
WMT COMPOSITE DBM
K083270 · Wrightmedicaltechnologyinc · Aug 2009
MASTERGRAFT STRIP
K082166 · Medtronic Sofamor Danek · Jun 2009
REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1
K082419 · Intra-Lock International, Inc. · May 2009
OSTEOCRETE BONE VOID FILLER
K071004 · Bone Solutions, Inc. · May 2009