Cleared Traditional

K013072 - CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)

K013072 is an FDA 510(k) clearance for CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP), manufactured by Synthes. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 439-day FDA review.

K013072 · Synthes · Orthopedic device
Download Printable Device Report (PDF)
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Nov 2002
Decision
439d
Days
Class 2
Risk

K013072 is an FDA 510(k) clearance for the CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP). Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Synthes (Paoli, US). The FDA issued a Cleared decision on November 26, 2002 after a review of 439 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 Synthes devices

FDA 510(k) Submission Details - K013072

510(k) Number K013072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2001
Decision Date November 26, 2002
Days to Decision 439 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
317d slower than avg
Panel avg: 122d · This submission: 439d
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 404
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K013072.
CALCIGEN PSI BONE GRAFT SUBSTITUTE
K030178 · Biomet, Inc. · Feb 2003
JAX
K010555 · Smith & Nephew, Inc. · Feb 2003
NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER
K023862 · Synthes (Usa) · Dec 2002
WMT-TCP BONE GRAFT SUBSTITUTE
K022629 · Wrightmedicaltechnologyinc · Nov 2002
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
K021551 · Biocomposites, Ltd. · Nov 2002
CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER
K011531 · Biomet, Inc. · Sep 2002