Cleared Traditional

K050789 - FORMAGRAFT COLLAGEN BONE GRAFT MATRIX

K050789 is an FDA 510(k) clearance for FORMAGRAFT COLLAGEN BONE GRAFT MATRIX, manufactured by R and D Medical, LLC. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K050789 · R and D Medical, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
60d
Days
Class 2
Risk

K050789 is an FDA 510(k) clearance for the FORMAGRAFT COLLAGEN BONE GRAFT MATRIX. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by R and D Medical, LLC (San Diego, US). The FDA issued a Cleared decision on May 27, 2005 after a review of 60 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.

FDA 510(k) Submission Details - K050789

510(k) Number K050789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2005
Decision Date May 27, 2005
Days to Decision 60 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
62d faster than avg
Panel avg: 122d · This submission: 60d
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 492
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K050789.
CONNEXUS
K050690 · Isotis Orthobiologics, Inc. · Jul 2005
SYNTHACER
K041177 · Medartis Medizinprodukte Und Forschung AG · Jun 2005
CALLOS IMPACT AND INJECT BONE VOID FILLER
K051123 · Skeletal Kinetics, LLC · Jun 2005
MODIFICATION TO MBCP
K043005 · Biomatlante · May 2005
CAMCERAM TCP
K050357 · Cam Implants B.V. · Apr 2005
OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER
K050490 · Medicrea · Apr 2005
K050789 · FORMAGRAFT COLLAGEN BONE GRAFT MATRIX
Download PDF FDA Summary R and D Medical, LLC