Cleared Traditional

K003954 - STIMULAN - CALCIUM SULFATE BONE VOID FI...

K003954 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 203-day FDA review.

K003954 · Biocomposites, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
203d
Days
Class 2
Risk

K003954 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 July 12, 2001 after a review of 203 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 - K003954

510(k) Number K003954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2000
Decision Date July 12, 2001
Days to Decision 203 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
81d slower than avg
Panel avg: 122d · This submission: 203d
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 K003954.
OSTEOSET BVF KIT
K010532 · Wrightmedicaltechnologyinc · Oct 2001
EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE
K011386 · Ebi, L.P. · Aug 2001
PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30
K004003 · Interpore Cross Intl. · Jul 2001
JAX GRANULES BONE VOID FILLER
K010557 · Smith & Nephew, Inc. · May 2001
SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)
K002362 · Synthes (Usa) · Nov 2000
PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,
K000515 · Interpore Cross Intl. · Sep 2000