Cleared Traditional

K991198 - DYNA-LOK PLUS SPINAL SYSTEM

K991198 is an FDA 510(k) clearance for DYNA-LOK PLUS 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 141-day FDA review.

K991198 · Sofamor Danek USA,Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
141d
Days
Class 2
Risk

K991198 is an FDA 510(k) clearance for the DYNA-LOK PLUS 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 August 27, 1999 after a review of 141 days - within the typical 510(k) review window.

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. 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 Sofamor Danek USA,Inc. devices

FDA 510(k) Submission Details - K991198

510(k) Number K991198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1999
Decision Date August 27, 1999
Days to Decision 141 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
19d slower than avg
Panel avg: 122d · This submission: 141d
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 K991198.
VERSALOK LOW BACK FIXATION SYSTEM
K992885 · Osteotech, Inc. · Nov 1999
CONTOUR SPINAL SYSTEM
K990986 · Ortho Development Corp. · Oct 1999
SYNTHES CERVIFIX SYSTEM
K991089 · Synthes Spine · Aug 1999
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
K991586 · Osteotech, Inc. · Jul 1999
SYNTHES CERVIFIX SYSTEM
K990965 · Synthes (Usa) · Jul 1999
OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTOR
K990922 · Howmedica Osteonics Corp. · Jun 1999