Cleared Traditional

K973704 - PROFUSION BONE VOID FILLER

K973704 is an FDA 510(k) clearance for PROFUSION BONE VOID FILLER, manufactured by Biogeneration. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K973704 · Biogeneration · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
186d
Days
Class 2
Risk

K973704 is an FDA 510(k) clearance for the PROFUSION BONE VOID FILLER. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Biogeneration (Lakeland, US). The FDA issued a Cleared decision on April 3, 1998 after a review of 186 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 Biogeneration devices

FDA 510(k) Submission Details - K973704

510(k) Number K973704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1997
Decision Date April 03, 1998
Days to Decision 186 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
64d slower than avg
Panel avg: 122d · This submission: 186d
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 352
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K973704.
PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE
K990131 · Interpore Cross Intl. · Mar 1999
STIMULAN- CALCIUM SULFATE BONE VOID FILLER
K982663 · Encore Orthopedics, Inc. · Feb 1999
PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L
K980817 · Interpore Intl. · Sep 1998
WRIGHT PLASTER OF PARIS PELLETS
K963562 · Wrightmedicaltechnologyinc · May 1997
WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION)
K963587 · Wrightmedicaltechnologyinc · Mar 1997
WRIGHT PLASTER OF PARIS PELLETS (SUBJECT TO REVISION)
K960978 · Wrightmedicaltechnologyinc · Jun 1996