Cleared Traditional

K030197 - BLACKSTONE POSTERIOR CERVICAL SYSTEM

K030197 is the FDA 510(k) clearance for BLACKSTONE POSTERIOR CERVICAL SYSTEM by Blackstone Medical, Inc.. It is a Class 2 Orthopedic device (product code KWP) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K030197 · Blackstone Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
142d
Days
Class 2
Risk

K030197 is an FDA 510(k) clearance for the BLACKSTONE POSTERIOR CERVICAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Blackstone Medical, Inc. (Springfield, US). The FDA issued a Cleared decision on June 12, 2003 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Blackstone Medical, Inc. devices

Submission Details

510(k) Number K030197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2003
Decision Date June 12, 2003
Days to Decision 142 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
20d slower than avg
Panel avg: 122d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 272
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K030197.
XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM
K031893 · Howmedica Osteonics Corp. · Jul 2003
MODIFICATION TO COLORADO 2 SPINAL SYSTEM
K030875 · Medtronic Sofamor Danek, Inc. · Jun 2003
VANTAGE ANTERIOR FIXATION SYSTEM
K031533 · Medtronic Sofamor Danek, Inc. · Jun 2003
MSD CABLE REDUCTION SYSTEM
K030816 · Medtronic Sofamor Danek · Jun 2003
MODIFICATION TO XIA STAINLESS STEEL SYSTEM
K031090 · Howmedica Osteonics Corp. · Apr 2003
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
K030241 · Blackstone Medical, Inc. · Feb 2003