Cleared Traditional

K070751 - ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY

K070751 is an FDA 510(k) clearance for ORTHOBLAST II DBM DEMINERALIZED BONE MA..., manufactured by Isotis Orthobiologics, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K070751 · Isotis Orthobiologics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
210d
Days
Class 2
Risk

K070751 is an FDA 510(k) clearance for the ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Isotis Orthobiologics, Inc. (Irvine, US). The FDA issued a Cleared decision on October 15, 2007 after a review of 210 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 Isotis Orthobiologics, Inc. devices

FDA 510(k) Submission Details - K070751

510(k) Number K070751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2007
Decision Date October 15, 2007
Days to Decision 210 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
88d slower than avg
Panel avg: 122d · This submission: 210d
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 309
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K070751.
MASTERGRAFT PUTTY
K071813 · Medtronic Sofamor Danek · Nov 2007
SYNTHES CHRONOS COMPOSITE
K071046 · Synthes (Usa) · Oct 2007
A-BSM BONE SUBSTITUTE MATERIAL
K072636 · Etex Corp. · Oct 2007
PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT
K072597 · Wrightmedicaltechnologyinc · Oct 2007
OSSIFUSE BONE SUBSTITUTE MATERIAL
K072355 · Etex Corp. · Sep 2007
MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE
K072384 · Kensey Nash Corp. · Sep 2007