Cleared Traditional

K051698 - MERRIES UNI-OSTEO, MODEL CS30250-CS10102

K051698 is an FDA 510(k) clearance for MERRIES UNI-OSTEO, manufactured by Merries International, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K051698 · Merries International, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
97d
Days
Class 2
Risk

K051698 is an FDA 510(k) clearance for the MERRIES UNI-OSTEO, MODEL CS30250-CS10102. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Merries International, Inc. (Shin-Tien, Taipei, TW). The FDA issued a Cleared decision on September 29, 2005 after a review of 97 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K051698

510(k) Number K051698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2005
Decision Date September 29, 2005
Days to Decision 97 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
25d faster than avg
Panel avg: 122d · This submission: 97d
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 K051698.
IGNITE BONE VOID FILLER KIT
K052913 · Wrightmedicaltechnologyinc · Nov 2005
GENEROS 80, GENEROS 60
K051914 · Berkeley Advanced Biomaterials, Inc. · Nov 2005
NOVABONE-BIOACTIVE SYNTHETIC GRAFT
K052494 · Novabone Products, LLC · Nov 2005
CERAMENT BONE VOID FILLER
K051951 · Bonesupport AB · Sep 2005
CONNEXUS, .5CC, MODEL 023000-005
K052098 · Isotis Orthobiologics, Inc. · Sep 2005
OSTEOMIMETIC SYNTHETIC BONE MATRIX
K051775 · Biomimetic Pharmaceuticals, Inc. · Sep 2005
K051698 · MERRIES UNI-OSTEO, MODEL CS30250-CS10102
Download PDF FDA Summary Merries International…