Cleared Special

K002959 - MODIFICATION TO ISOBAR SPINAL SYSTEM

K002959 is an FDA 510(k) clearance for MODIFICATION TO ISOBAR SPINAL SYSTEM, manufactured by Encore Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 24-day FDA review.

K002959 · Encore Orthopedics, Inc. · Orthopedic device
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Oct 2000
Decision
24d
Days
Class 2
Risk

K002959 is an FDA 510(k) clearance for the MODIFICATION TO ISOBAR SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on October 16, 2000 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Encore Orthopedics, Inc. devices

FDA 510(k) Submission Details - K002959

510(k) Number K002959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2000
Decision Date October 16, 2000
Days to Decision 24 days
Submission Type Special
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
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 282
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K002959.
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