Cleared Traditional

K070864 - BONEPLAST QS CALCIUM SULFATE BONE VOID FILLER

K070864 is an FDA 510(k) clearance for BONEPLAST QS CALCIUM SULFATE BONE VOID ..., manufactured by Biomet Osteobiologics. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K070864 · Biomet Osteobiologics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
65d
Days
Class 2
Risk

K070864 is an FDA 510(k) clearance for the BONEPLAST QS CALCIUM SULFATE BONE VOID FILLER. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Biomet Osteobiologics (Warsaw, US). The FDA issued a Cleared decision on June 1, 2007 after a review of 65 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biomet Osteobiologics devices

FDA 510(k) Submission Details - K070864

510(k) Number K070864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2007
Decision Date June 01, 2007
Days to Decision 65 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
57d faster than avg
Panel avg: 122d · This submission: 65d
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 310
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K070864.
VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE
K072184 · Orthovita, Inc. · Sep 2007
BONEMEDIK, AND BONEMEDIK-S
K070897 · Meta Biomed Co., Ltd. · Sep 2007
OSSIPRO BONE SUBSTITUTE MATERIAL
K062630 · Etex Corp. · Jun 2007
COPIOS BONE VOID FILLER SPONGE AND PASTE
K071237 · Kensey Nash Corp. · Jun 2007
PRO-DENSE BONE VOID FILLER
K070437 · Wrightmedicaltechnologyinc · May 2007
PRO OSTEON 500R
K063346 · Ebi, L.P. · Apr 2007