Cleared Traditional

BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEM (K974885) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K974885 · Blackstone Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
169d
Days
Class 2
Risk

K974885 is an FDA 510(k) clearance for the BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Blackstone Medical, Inc. (Springfield, US). The FDA issued a Cleared decision on June 17, 1998 after a review of 169 days - an extended review 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: 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 K974885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1997
Decision Date June 17, 1998
Days to Decision 169 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
47d slower than avg
Panel avg: 122d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 224
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K974885.
OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM
K982798 · Osteonics Corp. · Mar 1999
ANTERIOR CERVICAL PLATING SYSTEM
K984342 · United States Surgical, A Division of Tyco Healthc · Dec 1998
THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER)
K983899 · United States Surgical, A Division of Tyco Healthc · Dec 1998
AESCULAP ABC CERVICAL PLATING SYSTEM
K974706 · Aesculap, Inc. · Mar 1998
MICHELSON ANTERIOR CERVICAL PLATE SYSTEM
K974435 · Wrightmedicaltechnologyinc · Feb 1998
DEPUY MOTECH PEAK POLYAXIAL ANTERIOR CERVICAL PLATE SYSTEM
K971730 · Depuy, Inc. · Nov 1997