Cleared Special

K024060 - MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM

K024060 is an FDA 510(k) clearance for MODIFICATION TO ASNIS III CANNULATED SC..., manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 11-day FDA review.

K024060 · Howmedica Osteonics Corp. · Orthopedic device
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Dec 2002
Decision
11d
Days
Class 2
Risk

K024060 is an FDA 510(k) clearance for the MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on December 20, 2002 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Howmedica Osteonics Corp. devices

FDA 510(k) Submission Details - K024060

510(k) Number K024060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2002
Decision Date December 20, 2002
Days to Decision 11 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
111d faster than avg
Panel avg: 122d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 931
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K024060.
KOMPRESSOR SCREW SYSTEM
K024233 · Kinetikos Medical, Inc. · Feb 2003
PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM
K024086 · Biomet Orthopedics, Inc. · Jan 2003
COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197
K023922 · Coapt Systems, Inc. · Dec 2002
AAP CANNULATED SCREWS
K021233 · Aap Implantate AG · Dec 2002
MODULAR HEAD BONE SCREW
K022952 · Biomet, Inc. · Dec 2002
1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM
K023260 · Osteomed Corp. · Oct 2002