Cleared Traditional

K030369 - OPUS SPINAL SYSTEM

K030369 is the FDA 510(k) clearance for OPUS SPINAL SYSTEM by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K030369 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
185d
Days
Class 2
Risk

K030369 is an FDA 510(k) clearance for the OPUS SPINAL SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on August 8, 2003 after a review of 185 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K030369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2003
Decision Date August 08, 2003
Days to Decision 185 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
63d slower than avg
Panel avg: 122d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 661
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K030369.
ARROWHEAD SPINAL SYSTEM
K032560 · Medtronic Sofamor Danek · Mar 2004
EBI TOP LOADING MAS SPINAL FIXATION SYSTEM
K033312 · Ebi, L.P. · Jan 2004
CD HORIZON SPINAL SYSTEM
K032033 · Medtronic Sofamor Danek · Sep 2003
EBI SPINELINK - II SPINAL FIXATION SYSTEM
K031355 · Ebi, L.P. · Jul 2003
EBI SPINELINK SPINAL FIXATION SYSTEM
K031424 · Ebi, L.P. · Jul 2003
SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM
K030087 · Spinal Concepts, Inc. · Jul 2003