Cleared Traditional

PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC (K081558) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K081558 · Pioneer Surgical Technology · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2008
Decision
83d
Days
Class 2
Risk

K081558 is an FDA 510(k) clearance for the PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC. 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 August 25, 2008 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.

View all Pioneer Surgical Technology devices

Submission Details

510(k) Number K081558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2008
Decision Date August 25, 2008
Days to Decision 83 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
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.

Device Classification

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 195
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K081558.
MODIFICATION TO:MICROFUSE BONE VOID FILLER
K083232 · Globus Medical, Inc. · Dec 2008
TRICOS A RESORBABLE BONE SUBSTITUTE
K081717 · Baxter Healthcare Corp · Oct 2008
MODIFICATION TO MICROFUSE BONE VOID FILLER
K082442 · Globus Medical, Inc. · Oct 2008
MICROFUSE BONE VOID FILLER
K071187 · Globus Medical, Inc. · Dec 2007
POLYGRAFT BGS
K062607 · Smith & Nephew, Inc. · Nov 2007
SYNTHES CHRONOS COMPOSITE
K071046 · Synthes (Usa) · Oct 2007