Cleared Traditional

BIOSORB RESORBABLE VOID FILLER (K021963) - FDA 510(k) Clearance

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

K021963 · Sciences ET Bio Materiaux (Sbm) · Orthopedic device
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Jan 2003
Decision
228d
Days
Class 2
Risk

K021963 is an FDA 510(k) clearance for the BIOSORB RESORBABLE VOID FILLER. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Sciences ET Bio Materiaux (Sbm) (Lourdes, FR). The FDA issued a Cleared decision on January 28, 2003 after a review of 228 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 Sciences ET Bio Materiaux (Sbm) devices

Submission Details

510(k) Number K021963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2002
Decision Date January 28, 2003
Days to Decision 228 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
106d slower than avg
Panel avg: 122d · This submission: 228d
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 200
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K021963.
MIIG II BONE GRAFT SUBSTITUTE
K024336 · Wrightmedicaltechnologyinc · Mar 2003
CALCIGEN PSI BONE GRAFT SUBSTITUTE
K030178 · Biomet, Inc. · Feb 2003
JAX
K010555 · Smith & Nephew, Inc. · Feb 2003
NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER
K023862 · Synthes (Usa) · Dec 2002
WMT-TCP BONE GRAFT SUBSTITUTE
K022629 · Wrightmedicaltechnologyinc · Nov 2002
CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER
K011531 · Biomet, Inc. · Sep 2002