Cleared Traditional

BETA-TCP GRANULES (K120354) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K120354 · Skeletal Kinetics, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
409d
Days
Class 2
Risk

K120354 is an FDA 510(k) clearance for the BETA-TCP GRANULES. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Skeletal Kinetics, LLC (Cupertino, US). The FDA issued a Cleared decision on March 21, 2013 after a review of 409 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Skeletal Kinetics, LLC devices

Submission Details

510(k) Number K120354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2012
Decision Date March 21, 2013
Days to Decision 409 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
287d slower than avg
Panel avg: 122d · This submission: 409d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 195
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K120354.
KINEX BIOACTIVE
K130392 · Globus Medical, Inc. · Aug 2013
MASTERGRAFT STRIP
K130335 · Medtronic Sofamor Danek USA, Inc. · Apr 2013
PRO-DENSE BONE GRAFT SUBSTITUTE
K113871 · Wrightmedicaltechnologyinc · Mar 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
MICROFUSE PUTTY AND MICROFUSE ST MIS
K102392 · Globus Medical, Inc. · Dec 2010
WMT COMPOSITE DBM
K083270 · Wrightmedicaltechnologyinc · Aug 2009