Cleared Traditional

K982494 - BWM SPINE SYSTEM

K982494 is the FDA 510(k) clearance for BWM SPINE SYSTEM by Howmedica Corp.. It is a Class 2 Orthopedic device (product code KWP) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K982494 · Howmedica Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Sep 1998
Decision
53d
Days
Class 2
Risk

K982494 is an FDA 510(k) clearance for the BWM SPINE SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on September 8, 1998 after a review of 53 days - a notably fast clearance cycle.

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: 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 Corp. devices

Submission Details

510(k) Number K982494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1998
Decision Date September 08, 1998
Days to Decision 53 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
69d faster than avg
Panel avg: 122d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 266
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K982494.
TENOR SPINAL SYSTEM
K982490 · Sofamor Danek USA,Inc. · Oct 1998
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K982320 · Depuy, Inc. · Sep 1998
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEMS
K982511 · Depuy, Inc. · Sep 1998
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K982011 · DePuy Orthopaedics, Inc. · Aug 1998
AESCULAP SPINE SYSTEM ADDITIONAL COMPONENTS
K980121 · Aesculap, Inc. · Jun 1998
OSTEONICS LONG ARM CONTAINMENT RING
K981452 · Osteonics Corp. · May 1998