Cleared Traditional

K090401 - ORTHOSS

K090401 is an FDA 510(k) clearance for ORTHOSS, manufactured by Ed. Geistlich Soehne AG Fur Chemische Industrie. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 325-day FDA review.

K090401 · Ed. Geistlich Soehne AG Fur Chemische Industrie · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
325d
Days
Class 2
Risk

K090401 is an FDA 510(k) clearance for the ORTHOSS. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Ed. Geistlich Soehne AG Fur Chemische Industrie (Washington, US). The FDA issued a Cleared decision on January 8, 2010 after a review of 325 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K090401

510(k) Number K090401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2009
Decision Date January 08, 2010
Days to Decision 325 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
203d slower than avg
Panel avg: 122d · This submission: 325d
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 K090401.
BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY
K092046 · Berkeley Advanced Biomaterials, Inc. · Mar 2010
A-GRIX RESORBABLE BONE VOID FILLER
K091688 · Ag Digital Technology Corp. · Mar 2010
CARRIGEN
K093447 · Etex Corp. · Feb 2010
INTEGRA MOZAIK AND OS MOLDABLE MORSELS
K091302 · Integra LifeSciences Corporation · Dec 2009
DUOWEDGE SYNTHETIC BONE SUBSTITUTE
K073214 · Kasios · Dec 2009
PIONEER SURGICAL NANOSS BVF-E
K091031 · Pioneer Surgical Technology · Nov 2009
K090401 · ORTHOSS
Download PDF FDA Summary Ed. Geistlich Soehne …