Cleared Traditional

K984251 - XIA SPINE SYSTEM

K984251 is the FDA 510(k) clearance for XIA SPINE SYSTEM by Howmedica, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K984251 · Howmedica, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
89d
Days
Class 2
Risk

K984251 is an FDA 510(k) clearance for the XIA SPINE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Howmedica, Inc. (Rutherford, US). The FDA issued a Cleared decision on February 24, 1999 after a review of 89 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 Howmedica, Inc. devices

Submission Details

510(k) Number K984251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1998
Decision Date February 24, 1999
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
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 448
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K984251.
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
SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM
K990005 · Spinal Concepts, Inc. · Feb 1999
MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
K982875 · Danek Medical, Inc. · Jan 1999
ANTERIOR CERVICAL PLATING SYSTEM
K984342 · United States Surgical, A Division of Tyco Healthc · Dec 1998