Cleared Traditional

SYNTHACER (K041177) - FDA 510(k) Clearance

Also marketed or referenced as:
SYNTRICER

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

K041177 · Medartis Medizinprodukte Und Forschung AG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
414d
Days
Class 2
Risk

K041177 is an FDA 510(k) clearance for the SYNTHACER. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Medartis Medizinprodukte Und Forschung AG (Alling, DE). The FDA issued a Cleared decision on June 23, 2005 after a review of 414 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 Medartis Medizinprodukte Und Forschung AG devices

Submission Details

510(k) Number K041177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2004
Decision Date June 23, 2005
Days to Decision 414 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
292d slower than avg
Panel avg: 122d · This submission: 414d
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 201
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K041177.
MASTERGRAFT PUTTY BONE VOID FILLER
K051386 · Medtronic Vascular · Dec 2005
TRICOS T
K051722 · Baxter Healthcare Corp · Nov 2005
IGNITE BONE VOID FILLER KIT
K052913 · Wrightmedicaltechnologyinc · Nov 2005
SYNTHES (USA) CHRONOS
K043045 · Synthes (Usa) · Jan 2005
ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM
K041663 · Wrightmedicaltechnologyinc · Sep 2004
ALLOMATRIX PUTTY
K041168 · Wrightmedicaltechnologyinc · Aug 2004