Cleared Traditional

K964159 - CD SPINAL SYSTEM

K964159 is an FDA 510(k) clearance for CD SPINAL SYSTEM, manufactured by Sofamor Danek USA,Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 365-day FDA review.

K964159 · Sofamor Danek USA,Inc. · Orthopedic device
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Oct 1997
Decision
365d
Days
Class 2
Risk

K964159 is an FDA 510(k) clearance for the CD SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Sofamor Danek USA,Inc. (Memphis, US). The FDA issued a Cleared decision on October 16, 1997 after a review of 365 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Sofamor Danek USA,Inc. devices

FDA 510(k) Submission Details - K964159

510(k) Number K964159 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 16, 1996
Decision Date October 16, 1997
Days to Decision 365 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
243d slower than avg
Panel avg: 122d · This submission: 365d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

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 309
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K964159.
SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM
K980358 · Synthes (Usa) · Apr 1998
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K974573 · Depuy, Inc. · Feb 1998
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
K973868 · Osteotech, Inc. · Jan 1998
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
K971289 · Osteotech, Inc. · Jun 1997
EMPOWER ANTERIOR DIRECT SCREWS
K965224 · Smith & Nephew Richards, Inc. · May 1997
TITANIUM LIBERTY POSTERIOR SPINAL SYSTEM
K964254 · Sofamor Danek USA,Inc. · Apr 1997