Cleared Traditional

K002362 - SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)

K002362 is an FDA 510(k) clearance for SYNTHES CALCIUM SULFATE BONE VOID FILLE..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K002362 · Synthes (Usa) · Orthopedic device
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Nov 2000
Decision
90d
Days
Class 2
Risk

K002362 is an FDA 510(k) clearance for the SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS). Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on November 1, 2000 after a review of 90 days - within the typical 510(k) review window.

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 Synthes (Usa) devices

FDA 510(k) Submission Details - K002362

510(k) Number K002362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2000
Decision Date November 01, 2000
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 403
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K002362.
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
K003954 · Biocomposites, Ltd. · Jul 2001
JAX GRANULES BONE VOID FILLER
K010557 · Smith & Nephew, Inc. · May 2001
VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER
K994337 · Orthovita Co. · Dec 2000
PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150,
K000515 · Interpore Cross Intl. · Sep 2000
STIMULAN -CALCIUM SULFATE BONE VOID FILTER
K001724 · Biocomposites, Ltd. · Aug 2000
CALCIUM SULFATE PELLETS
K001559 · Howmedica Osteonics Corp. · Jun 2000