Cleared Traditional

K010911 - MACROPORE OS SPINAL SYSTEM

K010911 is an FDA 510(k) clearance for MACROPORE OS SPINAL 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 116-day FDA review.

K010911 · Macropore Biosurgery, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
116d
Days
Class 2
Risk

K010911 is an FDA 510(k) clearance for the MACROPORE OS SPINAL 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 20, 2001 after a review of 116 days - within the typical 510(k) review window.

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: 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 Macropore Biosurgery, Inc. devices

FDA 510(k) Submission Details - K010911

510(k) Number K010911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2001
Decision Date July 20, 2001
Days to Decision 116 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
6d faster than avg
Panel avg: 122d · This submission: 116d
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 K010911.
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW
K013558 · Blackstone Medical, Inc. · Jan 2002
CODMAN SLIM-LOC SYSTEM
K013877 · Codman & Shurtleff, Inc. · Dec 2001
MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM
K011556 · Aesculap, Inc. · Nov 2001
MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
K002824 · Aesculap, Inc. · May 2001
REFLEX ANTERIOR CERVICAL PLATE SYSTEM
K010115 · Howmedica Osteonics Corp. · Apr 2001
EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM
K010003 · Ebi, L.P. · Jan 2001