Cleared Traditional

K962486 - DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM

K962486 is an FDA 510(k) clearance for DEPUY MOTECH ANTERIOR COMPRESSION PLATE..., manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K962486 · Depuy, Inc. · Orthopedic device
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Dec 1996
Decision
184d
Days
Class 2
Risk

K962486 is an FDA 510(k) clearance for the DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 27, 1996 after a review of 184 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 Depuy, Inc. devices

FDA 510(k) Submission Details - K962486

510(k) Number K962486 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 26, 1996
Decision Date December 27, 1996
Days to Decision 184 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 122d · This submission: 184d
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 616
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K962486.
LIBERTY ANTERIOR SPINAL SYSTEM
K965193 · Sofamor Danek USA,Inc. · Mar 1997
ANTERIOR DYNAMIZED SYSTEM
K953978 · Acromed Corp. · Feb 1997
TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM
K964623 · Sofamor Danek USA,Inc. · Feb 1997
CD HORIZON ANTERIOR SPINAL SYSTEM
K963655 · Sofamor Danek USA,Inc. · Nov 1996
EBI ANTERIOR CERVICAL SPINE SYSTEM
K955730 · Electro-Biology, Inc. · Mar 1996
SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION
K940744 · Sofamor Co. · Jan 1996