Cleared Traditional

K991678 - WHITESIDE BIOMECHANICS SPINAL SYSTEM

K991678 is an FDA 510(k) clearance for WHITESIDE BIOMECHANICS SPINAL SYSTEM, manufactured by Whiteside Biomechanics, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K991678 · Whiteside Biomechanics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
87d
Days
Class 2
Risk

K991678 is an FDA 510(k) clearance for the WHITESIDE BIOMECHANICS SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Whiteside Biomechanics, Inc. (Creve Coeur, US). The FDA issued a Cleared decision on August 12, 1999 after a review of 87 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 Whiteside Biomechanics, Inc. devices

FDA 510(k) Submission Details - K991678

510(k) Number K991678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1999
Decision Date August 12, 1999
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

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 523
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K991678.
HOWMEDICA OSTEONICS ACCP SYSTEM CORTICAL SCREWS
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MOSS MIAMI 6.35MM POLYAXIAL SCREW
K992168 · Depuyacromed · Sep 1999
PREMIER ANTERIOR CERVICAL PLATE SYSTEM
K992110 · Sofamor Danek USA · Sep 1999
OSTEONICS ACCP SYSTEM LINE EXTENSION
K992344 · Howmedica Osteonics Corp. · Jul 1999
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K991092 · Electro-Biology, Inc. · Apr 1999
OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM
K982798 · Osteonics Corp. · Mar 1999