Cleared Traditional

K001535 - ZENITH PLATE SYSTEM

K001535 is an FDA 510(k) clearance for ZENITH PLATE SYSTEM, manufactured by Ortho Tec, LLC. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K001535 · Ortho Tec, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
307d
Days
Class 2
Risk

K001535 is an FDA 510(k) clearance for the ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Ortho Tec, LLC (Pleasant Hill, US). The FDA issued a Cleared decision on March 20, 2001 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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. Elevated predicate reliance profile. 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 Ortho Tec, LLC devices

FDA 510(k) Submission Details - K001535

510(k) Number K001535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2000
Decision Date March 20, 2001
Days to Decision 307 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
185d slower than avg
Panel avg: 122d · This submission: 307d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 336
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K001535.
CD HORIZON SPINAL SYSTEM
K011508 · Medtronic Sofamor Danek, Inc. · Jun 2001
BUTTERFLY PLATE FUNCTION SYSTEM
K010632 · Medtronic Sofamor Danek USA, Inc. · May 2001
MODIFICATION TO SYNERGY SPINAL SYSTEM
K010515 · Interpore Cross Intl. · Mar 2001
PARSFIX CABLE-SCREW SYSTEM
K003351 · Spinal Concepts, Inc. · Jan 2001
ISOLA CLOSED DUAL ROD CONNECTOR
K003822 · Depuyacromed · Jan 2001
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
K002733 · Depuyacromed · Dec 2000