Cleared Traditional

K043045 - SYNTHES (USA) CHRONOS

K043045 is an FDA 510(k) clearance for SYNTHES (USA) CHRONOS, manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K043045 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
64d
Days
Class 2
Risk

K043045 is an FDA 510(k) clearance for the SYNTHES (USA) CHRONOS. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on January 7, 2005 after a review of 64 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.

View all Synthes (Usa) devices

FDA 510(k) Submission Details - K043045

510(k) Number K043045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2004
Decision Date January 07, 2005
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
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 398
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K043045.
OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE
K043420 · Regeneration Technologies, Inc. · Feb 2005
NANOSS BONE VOID FILLER
K050025 · Angstrom Medica, Inc. · Feb 2005
ALLOGRAN-N-BONE VOID FILLER
K043514 · Biocomposites, Ltd. · Jan 2005
BF+
K043347 · Ldr Spine USA · Jan 2005
CEMENTEK LV
K042911 · Teknimed, S.A. · Dec 2004
BIOPLUS
K042636 · Berkeley Advanced Biomaterials, Inc. · Dec 2004