Cleared Traditional

K030197 - BLACKSTONE POSTERIOR CERVICAL SYSTEM

K030197 is an FDA 510(k) clearance for BLACKSTONE POSTERIOR CERVICAL SYSTEM, manufactured by Blackstone Medical, Inc.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K030197

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.

KWP Device Classification - Class 2, Special Controls

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 384
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K030197.
MODIFICATION TO COLORADO 2 SPINAL SYSTEM
K030875 · Medtronic Sofamor Danek, Inc. · Jun 2003
ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03
K031452 · Ortho Tec, LLC · 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