Cleared Traditional

K990005 - SPINAL CONCEPTS

K990005 is the FDA 510(k) clearance for SPINAL CONCEPTS by Spinal Concepts, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K990005 · Spinal Concepts, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
39d
Days
Class 2
Risk

K990005 is an FDA 510(k) clearance for the SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Spinal Concepts, Inc. (Austin, US). The FDA issued a Cleared decision on February 12, 1999 after a review of 39 days - a notably fast clearance 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: 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 Spinal Concepts, Inc. devices

Submission Details

510(k) Number K990005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1999
Decision Date February 12, 1999
Days to Decision 39 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
83d faster than avg
Panel avg: 122d · This submission: 39d
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 438
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K990005.
OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM
K982798 · Osteonics Corp. · Mar 1999
MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM
K990603 · Danek Medical, Inc. · Mar 1999
XIA SPINE SYSTEM
K984251 · Howmedica, Inc. · Feb 1999
MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
K982875 · Danek Medical, Inc. · Jan 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