Cleared Traditional

BIOFILL BONE VOID FILLER (K040454) - FDA 510(k) Clearance

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

K040454 · Scient'X · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
74d
Days
Class 2
Risk

K040454 is an FDA 510(k) clearance for the BIOFILL BONE VOID FILLER. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Scient'X (Round Rock, US). The FDA issued a Cleared decision on May 7, 2004 after a review of 74 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 Scient'X devices

Submission Details

510(k) Number K040454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2004
Decision Date May 07, 2004
Days to Decision 74 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
48d faster than avg
Panel avg: 122d · This submission: 74d
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 K040454.
EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE
K040755 · Exactech, Inc. · Jun 2004
JAX-TCP
K033552 · Smith & Nephew, Inc. · Jun 2004
HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -15
K040381 · Arthrex, Inc. · May 2004
CALCIGEN -NAP BONE VOID FILLER
K033611 · Biomet, Inc. · Apr 2004
OSTEOSET DBM PELLETS, MODEL 8600-48XX
K022828 · Wrightmedicaltechnologyinc · Apr 2004
ALLOMATRIX MODEL# 86
K020895 · Wrightmedicaltechnologyinc · Mar 2004