Cleared Special

K992344 - OSTEONICS ACCP SYSTEM LINE EXTENSION

K992344 is an FDA 510(k) clearance for OSTEONICS ACCP SYSTEM LINE EXTENSION, manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 16-day FDA review.

K992344 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
16d
Days
Class 2
Risk

K992344 is an FDA 510(k) clearance for the OSTEONICS ACCP SYSTEM LINE EXTENSION. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on July 30, 1999 after a review of 16 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Howmedica Osteonics Corp. devices

FDA 510(k) Submission Details - K992344

510(k) Number K992344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1999
Decision Date July 30, 1999
Days to Decision 16 days
Submission Type Special
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
106d faster than avg
Panel avg: 122d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

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 592
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K992344.
MOSS MIAMI 6.35MM POLYAXIAL SCREW
K992168 · Depuyacromed · Sep 1999
PREMIER ANTERIOR CERVICAL PLATE SYSTEM
K992110 · Sofamor Danek USA · Sep 1999
WHITESIDE BIOMECHANICS SPINAL SYSTEM
K991678 · Whiteside Biomechanics, Inc. · Aug 1999
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K991092 · Electro-Biology, Inc. · Apr 1999
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