Cleared Traditional

K013960 - APATIGHT HA-BONE GRAFT SUBSTITUTE

K013960 is an FDA 510(k) clearance for APATIGHT HA-BONE GRAFT SUBSTITUTE, manufactured by Cerabio, LLC. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K013960 · Cerabio, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
171d
Days
Class 2
Risk

K013960 is an FDA 510(k) clearance for the APATIGHT HA-BONE GRAFT SUBSTITUTE. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Cerabio, LLC (Prescott, US). The FDA issued a Cleared decision on May 23, 2002 after a review of 171 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 Cerabio, LLC devices

FDA 510(k) Submission Details - K013960

510(k) Number K013960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2001
Decision Date May 23, 2002
Days to Decision 171 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
49d slower than avg
Panel avg: 122d · This submission: 171d
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 365
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K013960.
NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE
K021336 · Novabone Products, LLC · Jul 2002
MASTERGRAFT RESORBABLE CERAMIC
K020986 · Medtronic Sofamor Danek, Inc. · Jul 2002
CALCIGEN-S BONE VOID FILER
K013790 · Biomet Orthopedics, Inc. · Jun 2002
CONDUIT TCP GRANULES
K014053 · Depuyacromed · Mar 2002
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K012506 · Medtronic Sofamor Danek USA, Inc. · Mar 2002
NORIAN SRS BONE VOID FILLER
K011897 · Synthes (Usa) · Dec 2001