Cleared Traditional

K050642 - ORTHOBLAST II PUTTY AND PASTE

K050642 is an FDA 510(k) clearance for ORTHOBLAST II PUTTY AND PASTE, manufactured by Isotis Orthobiologics, Inc.. The device is a Class 2 Orthopedic device with product code MBP cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K050642 · Isotis Orthobiologics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
269d
Days
Class 2
Risk

K050642 is an FDA 510(k) clearance for the ORTHOBLAST II PUTTY AND PASTE. Classified as Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) (product code MBP), Class II - Special Controls.

Submitted by Isotis Orthobiologics, Inc. (Irvine, US). The FDA issued a Cleared decision on December 5, 2005 after a review of 269 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 - K050642

510(k) Number K050642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2005
Decision Date December 05, 2005
Days to Decision 269 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
147d slower than avg
Panel avg: 122d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBP Device Classification - Class 2, Special Controls

Product Code MBP Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
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.