Cleared Traditional

K013885 - BLACKSTONE SPINAL FIXATION SYSTEM POSTE...

K013885 is the FDA 510(k) clearance for BLACKSTONE SPINAL FIXATION SYSTEM POSTE... by Blackstone Medical, Inc.. It is a Class 2 Orthopedic device (product code MNI) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K013885 · Blackstone Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
70d
Days
Class 2
Risk

K013885 is an FDA 510(k) clearance for the BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS. 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 1, 2002 after a review of 70 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Blackstone Medical, Inc. devices

Submission Details

510(k) Number K013885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2001
Decision Date February 01, 2002
Days to Decision 70 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
52d faster than avg
Panel avg: 122d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 159
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K013885.
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K021106 · Medtronic Sofamor Danek, Inc. · May 2002
SYNTHES DUAL-OPENING USS
K020517 · Synthes (Usa) · Apr 2002
PASS SPINAL SYSTEM
K013431 · Encore Orthopedics, Inc. · Nov 2001
TRI-FIX SPINAL FIXATION SYSTEM
K013403 · Endius, Inc. · Nov 2001
SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL SYSTEM
K013222 · Depuyacromed · Nov 2001