Cleared Traditional

K992012 - WILTSE SYSTEM

K992012 is an FDA 510(k) clearance for WILTSE SYSTEM, manufactured by Advanced Spine Fixation Systems, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K992012 · Advanced Spine Fixation Systems, Inc. · Orthopedic device
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Feb 2000
Decision
234d
Days
Class 2
Risk

K992012 is an FDA 510(k) clearance for the WILTSE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Advanced Spine Fixation Systems, Inc. (Irvine, US). The FDA issued a Cleared decision on February 4, 2000 after a review of 234 days - an extended review 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: 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 Advanced Spine Fixation Systems, Inc. devices

FDA 510(k) Submission Details - K992012

510(k) Number K992012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1999
Decision Date February 04, 2000
Days to Decision 234 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 122d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

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 527
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K992012.
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DOGBONE ACFS
K994383 · Theken Surgical · Feb 2000
MODIFICATION TO ISOLA SPINAL SYSTEM
K993030 · Depuyacromed · Dec 1999
K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM
K990959 · Spineology, Inc. · Dec 1999