Cleared Special

K040034 - BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER

K040034 is an FDA 510(k) clearance for BLACKSTONE ASCENT POCT SYSTEM LATERAL O..., manufactured by Blackstone Medical, Inc.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 34-day FDA review.

K040034 · Blackstone Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
34d
Days
Class 2
Risk

K040034 is an FDA 510(k) clearance for the BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Blackstone Medical, Inc. (Springfield, US). The FDA issued a Cleared decision on February 11, 2004 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Blackstone Medical, Inc. devices

FDA 510(k) Submission Details - K040034

510(k) Number K040034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2004
Decision Date February 11, 2004
Days to Decision 34 days
Submission Type Special
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
88d faster than avg
Panel avg: 122d · This submission: 34d
Pathway characteristics
Modification to existing cleared device.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 266
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K040034.
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K040583 · Medtronic Sofamor Danek · Mar 2004
MODIFICATION TO ORIA TOP CLIP SYSTEM
K040346 · Ortho Tec, LLC · Mar 2004
STRYKER SPINE OASYS SYSTEM
K032394 · Howmedica Osteonics Corp. · Feb 2004
POSTERIOR CABLE SCREW
K022908 · Pioneer Surgical Technology · Jan 2004
MODIFICATION TO EQUATION FIXATION SYSTEM
K033495 · Medtronic Sofamor Danek, Inc. · Dec 2003
ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS
K030958 · Ortho Tec, LLC · Nov 2003