Cleared Traditional

K990986 - CONTOUR SPINAL SYSTEM

K990986 is an FDA 510(k) clearance for CONTOUR SPINAL SYSTEM, manufactured by Ortho Development Corp.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K990986 · Ortho Development Corp. · Orthopedic device
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Oct 1999
Decision
204d
Days
Class 2
Risk

K990986 is an FDA 510(k) clearance for the CONTOUR SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on October 14, 1999 after a review of 204 days - an extended review 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: 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 Ortho Development Corp. devices

FDA 510(k) Submission Details - K990986

510(k) Number K990986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1999
Decision Date October 14, 1999
Days to Decision 204 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
82d slower than avg
Panel avg: 122d · This submission: 204d
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 281
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K990986.
DYNA-LOK CLASSIC SPINAL SYSTEM
K001532 · Medtronic Sofamor Danek, Inc. · Jun 2000
MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS
K001105 · Depuyacromed · Apr 2000
SYNTHES CERVIFIX SYSTEM
K994187 · Synthes (Usa) · Dec 1999
SYNTHES CERVIFIX SYSTEM
K991089 · Synthes Spine · Aug 1999
DYNA-LOK PLUS SPINAL SYSTEM
K991198 · Sofamor Danek USA,Inc. · Aug 1999
SYNTHES CERVIFIX SYSTEM
K990965 · Synthes (Usa) · Jul 1999