Cleared Special

OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS (K984302) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K984302 · Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
16d
Days
Class 2
Risk

K984302 is an FDA 510(k) clearance for the OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on December 18, 1998 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Osteonics Corp. devices

Submission Details

510(k) Number K984302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1998
Decision Date December 18, 1998
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.

Device Classification

Product Code MNH Orthosis, Spondylolisthesis Spinal 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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 38
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K984302.
SOCON SPINAL SYSTEM
K993551 · Aesculap, Inc. · Jan 2000
OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM
K991055 · Howmedica Osteonics Corp. · Aug 1999
SYNTHES PEDIATRIC ROD SYSTEM
K991552 · Synthes (Usa) · Jun 1999
OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS
K983152 · Osteonics Corp. · Sep 1998
TITANIUM SPINAL ROD SYSTEM
K980862 · United States Surgical, A Division of Tyco Healthc · May 1998
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K980447 · DePuy Orthopaedics, Inc. · Apr 1998