Cleared Traditional

K021551 - STIMULAN - CALCIUM SULFATE BONE VOID FI...

K021551 is an FDA 510(k) clearance for STIMULAN - CALCIUM SULFATE BONE VOID FI..., manufactured by Biocomposites, Ltd.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K021551 · Biocomposites, Ltd. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Nov 2002
Decision
172d
Days
Class 2
Risk

K021551 is an FDA 510(k) clearance for the STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Biocomposites, Ltd. (Stoke On Trent, GB). The FDA issued a Cleared decision on November 1, 2002 after a review of 172 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 Biocomposites, Ltd. devices

FDA 510(k) Submission Details - K021551

510(k) Number K021551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2002
Decision Date November 01, 2002
Days to Decision 172 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
50d slower than avg
Panel avg: 122d · This submission: 172d
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 290
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K021551.
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
NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE
K021336 · Novabone Products, LLC · Jul 2002
MASTERGRAFT RESORBABLE CERAMIC
K020986 · Medtronic Sofamor Danek, Inc. · Jul 2002