Cleared Traditional

VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER (K994337) - FDA 510(k) Clearance

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

K994337 · Orthovita Co. · Orthopedic device
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Dec 2000
Decision
357d
Days
Class 2
Risk

K994337 is an FDA 510(k) clearance for the VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Orthovita Co. (Malver, US). The FDA issued a Cleared decision on December 14, 2000 after a review of 357 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Orthovita Co. devices

Submission Details

510(k) Number K994337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1999
Decision Date December 14, 2000
Days to Decision 357 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
235d slower than avg
Panel avg: 122d · This submission: 357d
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 201
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K994337.
BSM BONE SUBSTITUTE MATERIAL
K011048 · DePuy Orthopaedics, Inc. · Nov 2001
OSTEOSET BVF KIT
K010532 · Wrightmedicaltechnologyinc · Oct 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
CALCIUM SULFATE PELLETS
K001559 · Howmedica Osteonics Corp. · Jun 2000
WRIGHT PLASTER OF PARIS PELLETS
K963562 · Wrightmedicaltechnologyinc · May 1997