Cleared Traditional

K090641 - CURIOS

K090641 is an FDA 510(k) clearance for CURIOS, manufactured by Progentix Orthobiology BV. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K090641 · Progentix Orthobiology BV · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
227d
Days
Class 2
Risk

K090641 is an FDA 510(k) clearance for the CURIOS. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Progentix Orthobiology BV (Bilthoven, NL). The FDA issued a Cleared decision on October 23, 2009 after a review of 227 days - an extended review cycle.

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. Standard predicate reliance. 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 Progentix Orthobiology BV devices

FDA 510(k) Submission Details - K090641

510(k) Number K090641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2009
Decision Date October 23, 2009
Days to Decision 227 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
105d slower than avg
Panel avg: 122d · This submission: 227d
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 307
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K090641.
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
KAINOS+
K090387 · Signus Medizintechnik GmbH · Sep 2009
DBX DEMINERALIZED BONE MATRIX PUTTY
K091218 · Musculoskeletal Transplant Foundation · Sep 2009
EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE
K090855 · Etex Corp. · Sep 2009