Cleared Special

K001105 - MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AN...

K001105 is an FDA 510(k) clearance for MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AN..., manufactured by Depuyacromed. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 19-day FDA review.

K001105 · Depuyacromed · Orthopedic device
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Apr 2000
Decision
19d
Days
Class 2
Risk

K001105 is an FDA 510(k) clearance for the MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS. 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 April 24, 2000 after a review of 19 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 - K001105

510(k) Number K001105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2000
Decision Date April 24, 2000
Days to Decision 19 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
103d faster than avg
Panel avg: 122d · This submission: 19d
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 K001105.
E-Z LINK CROSS CONNECTOR
K001372 · Depuyacromed · Jul 2000
SPINE SYSTEM EVOLUTION
K001080 · Aesculap, Inc. · Jun 2000
DYNA-LOK CLASSIC SPINAL SYSTEM
K001532 · Medtronic Sofamor Danek, Inc. · Jun 2000
SYNTHES CERVIFIX SYSTEM
K994187 · Synthes (Usa) · Dec 1999
CONTOUR SPINAL SYSTEM
K990986 · Ortho Development Corp. · Oct 1999
SYNTHES CERVIFIX SYSTEM
K991089 · Synthes Spine · Aug 1999