Cleared Traditional

ABC CERVICAL PLATING SYSTEM (K000486) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K000486 · Aesculap, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
60d
Days
Class 2
Risk

K000486 is an FDA 510(k) clearance for the ABC CERVICAL PLATING SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on April 14, 2000 after a review of 60 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 Aesculap, Inc. devices

Submission Details

510(k) Number K000486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2000
Decision Date April 14, 2000
Days to Decision 60 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
62d faster than avg
Panel avg: 122d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 238
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K000486.
XIA SPINE SYSTEM
K002858 · Howmedica Osteonics Corp. · Oct 2000
MODIFICATION TO CENTAUR SPINAL SYSTEM
K001844 · Howmedica Osteonics Corp. · Jul 2000
XIA SPINE SYSTEM
K001272 · Howmedica Osteonics Corp. · May 2000
CENTAUR SPINAL SYSTEM
K994347 · Howmedica Osteonics Corp. · Mar 2000
SPIRAL RADIUS RODDING SYSTEM
K000009 · United States Surgical, A Division of Tyco Healthc · Mar 2000
XIA SPINAL SYSTEM C-C ADAPTOR
K992792 · Howmedica Osteonics Corp. · Nov 1999