Cleared Traditional

K041177 - SYNTHACER

Also marketed or referenced as:
SYNTRICER

K041177 is an FDA 510(k) clearance for SYNTHACER, manufactured by Medartis Medizinprodukte Und Forschung AG. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 414-day FDA review.

K041177 · Medartis Medizinprodukte Und Forschung AG · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K041177

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
Combination Product No
PCCP Authorized No
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.

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 492
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K041177.
AFT
K042125 · Musculoskeletal Transplant Foundation · Jul 2005
MARROW PLUS (M+)
K051695 · Berkeley Advanced Biomaterials, Inc. · Jul 2005
CONNEXUS
K050690 · Isotis Orthobiologics, Inc. · Jul 2005
CALLOS IMPACT AND INJECT BONE VOID FILLER
K051123 · Skeletal Kinetics, LLC · Jun 2005
FORMAGRAFT COLLAGEN BONE GRAFT MATRIX
K050789 · R and D Medical, LLC · May 2005
MODIFICATION TO MBCP
K043005 · Biomatlante · May 2005
K041177 · SYNTHACER
Download PDF FDA Summary Medartis Medizinprodu…