Cleared Traditional

K041105 - MACROPORE HYDROSORB SPINE SYSTEM

K041105 is an FDA 510(k) clearance for MACROPORE HYDROSORB SPINE SYSTEM, manufactured by Macropore Biosurgery, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K041105 · Macropore Biosurgery, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
89d
Days
Class 2
Risk

K041105 is an FDA 510(k) clearance for the MACROPORE HYDROSORB SPINE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Macropore Biosurgery, Inc. (San Diego, US). The FDA issued a Cleared decision on July 28, 2004 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Macropore Biosurgery, Inc. devices

FDA 510(k) Submission Details - K041105

510(k) Number K041105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2004
Decision Date July 28, 2004
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 449
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K041105.
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K042025 · Medtronic Sofamor Danek, Inc. · Aug 2004
EXPEDIUM ANTERIOR SPINE SYSTEM
K041205 · Depuy Spine, Inc. · Aug 2004
NUVASIVE ANTERIOR CERVICAL PLATE SYSTEM
K041447 · Nuvasive, Inc. · Aug 2004
C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM
K041794 · Interpore Cross Intl. · Jul 2004
CD HORIZON SPINAL SYSTEM
K041460 · Medtronic Sofamor Danek USA, Inc. · Jul 2004
ASSURE ANTERIOR CERVICAL PLATE SYSTEM
K040721 · Globus Medical, Inc. · Jun 2004