Cleared Traditional

K120141 - KENSEY NASH BONE VOID FILLER XC

K120141 is an FDA 510(k) clearance for KENSEY NASH BONE VOID FILLER XC, manufactured by Kensey Nash Cororation. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K120141 · Kensey Nash Cororation · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
107d
Days
Class 2
Risk

K120141 is an FDA 510(k) clearance for the KENSEY NASH BONE VOID FILLER XC. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Kensey Nash Cororation (Exton, US). The FDA issued a Cleared decision on May 4, 2012 after a review of 107 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 - K120141

510(k) Number K120141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received January 18, 2012
Decision Date May 04, 2012
Days to Decision 107 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
15d faster than avg
Panel avg: 122d · This submission: 107d
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 K120141.
MTF NEW BONE VOID FILLER
K121313 · Musculoskeletal Transplant Foundation · Jan 2013
OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC,
K121989 · Exactech, Inc. · Nov 2012
BICERA (TM) RESORBABLE BONE SUBSTITUTE
K110949 · Wiltrom Corporation Limited · Sep 2012
NANOFUSE DBM
K120279 · Nanotherapeutics · Apr 2012
APACERAM BONE GRAFT SUBSTITUTE
K120602 · Hoya Corporation · Mar 2012
B-GENIN, R-GENIN
K113791 · Berkeley Advanced Biomaterials, Inc. · Mar 2012
K120141 · KENSEY NASH BONE VOID FILLER XC
Download PDF FDA Summary Kensey Nash Cororation