Cleared Special

K993603 - WICHITA FUSION NAIL FULLY THREADED SELF...

K993603 is the FDA 510(k) clearance for WICHITA FUSION NAIL FULLY THREADED SELF... by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Special 510(k) pathway after a 25-day FDA review.

K993603 · Howmedica Osteonics Corp. · Orthopedic device
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Nov 1999
Decision
25d
Days
Class 2
Risk

K993603 is an FDA 510(k) clearance for the WICHITA FUSION NAIL FULLY THREADED SELF-TAPPING SCREW. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Rutherford, US). The FDA issued a Cleared decision on November 19, 1999 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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

Submission Details

510(k) Number K993603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1999
Decision Date November 19, 1999
Days to Decision 25 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
97d faster than avg
Panel avg: 122d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 328
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K993603.
BROOKER FEMORAL NAILS
K002278 · Biomet Orthopedics, Inc. · Oct 2000
BROOKER TIBIA NAILS
K002057 · Biomet Orthopedics, Inc. · Oct 2000
TITANIUM PEDIATRIC FEMORAL NAIL
K993956 · Biomet, Inc. · Dec 1999
MODIFIED LONG LENGTH GAMMA NAIL
K993670 · Howmedica Osteonics Corp. · Nov 1999
OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY
K992063 · Howmedica Osteonics Corp. · Sep 1999
ULTIMAX ANKLE FUSION ROD SYSTEM
K991790 · Encore Orthopedics, Inc. · Aug 1999