Cleared Traditional

K994337 - VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER

K994337 is an FDA 510(k) clearance for VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BO..., manufactured by Orthovita Co.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 357-day FDA review.

K994337 · Orthovita Co. · Orthopedic device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K994337

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
Combination Product No
PCCP Authorized No
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.

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 383
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K994337.
PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30
K004003 · Interpore Cross Intl. · Jul 2001
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
K003954 · Biocomposites, Ltd. · 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
STIMULAN -CALCIUM SULFATE BONE VOID FILTER
K001724 · Biocomposites, Ltd. · Aug 2000