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)
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.

View all Ed. Geistlich Soehne AG Fur Chemische Industrie devices

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
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 309
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K090401.
SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
K092608 · Collagen Matrix, Inc. · May 2010
NANOSS BONE VOID FILLER
K100361 · Pioneer Surgical Technology · Apr 2010
CARRIGEN
K093447 · Etex Corp. · Feb 2010
INTEGRA MOZAIK AND OS MOLDABLE MORSELS
K091302 · Integra LifeSciences Corporation · Dec 2009
PIONEER SURGICAL NANOSS BVF-E
K091031 · Pioneer Surgical Technology · Nov 2009
ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE
K091607 · Etex Corp. · Nov 2009