Cleared Traditional

K091607 - ALPHA-BSM

K091607 is an FDA 510(k) clearance for ALPHA-BSM, manufactured by Etex Corp.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K091607 · Etex Corp. · Orthopedic device
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Nov 2009
Decision
152d
Days
Class 2
Risk

K091607 is an FDA 510(k) clearance for the ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Etex Corp. (Cambridge, US). The FDA issued a Cleared decision on November 2, 2009 after a review of 152 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 Etex Corp. devices

FDA 510(k) Submission Details - K091607

510(k) Number K091607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2009
Decision Date November 02, 2009
Days to Decision 152 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
30d slower than avg
Panel avg: 122d · This submission: 152d
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 299
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K091607.
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
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