Cleared Traditional

K021963 - BIOSORB RESORBABLE VOID FILLER

K021963 is an FDA 510(k) clearance for BIOSORB RESORBABLE VOID FILLER, manufactured by Sciences ET Bio Materiaux (Sbm). The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K021963 · Sciences ET Bio Materiaux (Sbm) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K021963

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.

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 309
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
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
K021551 · Biocomposites, Ltd. · Nov 2002