Cleared Special

K022623 - 5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS ...

K022623 is the FDA 510(k) clearance for 5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS ... by Depuyacromed. It is a Class 2 Orthopedic device (product code KWP) cleared through the Special 510(k) pathway after a 20-day FDA review.

K022623 · Depuyacromed · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
20d
Days
Class 2
Risk

K022623 is an FDA 510(k) clearance for the 5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM). 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 August 27, 2002 after a review of 20 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

Submission Details

510(k) Number K022623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2002
Decision Date August 27, 2002
Days to Decision 20 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
102d faster than avg
Panel avg: 122d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 K022623.
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K023555 · Medtronic Sofamor Danek, Inc. · Nov 2002
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
K023498 · Blackstone Medical, Inc. · Nov 2002
MODIFICATION TO TENOR SPINAL SYSTEM
K022191 · Medtronic Sofamor Danek, Inc. · Aug 2002
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K021061 · Medtronic Sofamor Danek · Jul 2002
XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM
K022070 · Medtronic Sofamor Danek, Inc. · Jul 2002
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K022015 · Medtronic Sofamor Danek, Inc. · Jul 2002