Cleared Special

K003822 - ISOLA CLOSED DUAL ROD CONNECTOR

K003822 is an FDA 510(k) clearance for ISOLA CLOSED DUAL ROD CONNECTOR, manufactured by Depuyacromed. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 28-day FDA review.

K003822 · Depuyacromed · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
28d
Days
Class 2
Risk

K003822 is an FDA 510(k) clearance for the ISOLA CLOSED DUAL ROD CONNECTOR. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Depuyacromed (Raynham, US). The FDA issued a Cleared decision on January 8, 2001 after a review of 28 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 Depuyacromed devices

FDA 510(k) Submission Details - K003822

510(k) Number K003822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2000
Decision Date January 08, 2001
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
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 281
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K003822.
BUTTERFLY PLATE FUNCTION SYSTEM
K010632 · Medtronic Sofamor Danek USA, Inc. · May 2001
MODIFICATION TO SYNERGY SPINAL SYSTEM
K010515 · Interpore Cross Intl. · Mar 2001
PARSFIX CABLE-SCREW SYSTEM
K003351 · Spinal Concepts, Inc. · Jan 2001
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
K002733 · Depuyacromed · Dec 2000
SIMPLICITY SPINAL SYSTEM
K002103 · Medtronic Sofamor Danek USA, Inc. · Nov 2000
MODIFICATION TO ISOBAR SPINAL SYSTEM
K002959 · Encore Orthopedics, Inc. · Oct 2000