Cleared Special

K033763 - MODIFICATION TO SLIM GLIDING NAIL SYSTEM

K033763 is an FDA 510(k) clearance for MODIFICATION TO SLIM GLIDING NAIL SYSTEM, manufactured by Plus Orthopedics. The device is a Class 2 Orthopedic device with product code KTT cleared through the Special 510(k) pathway after a 16-day FDA review.

K033763 · Plus Orthopedics · Orthopedic device
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Dec 2003
Decision
16d
Days
Class 2
Risk

K033763 is an FDA 510(k) clearance for the MODIFICATION TO SLIM GLIDING NAIL SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Plus Orthopedics (San Diego, US). The FDA issued a Cleared decision on December 18, 2003 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Plus Orthopedics devices

FDA 510(k) Submission Details - K033763

510(k) Number K033763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2003
Decision Date December 18, 2003
Days to Decision 16 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
106d faster than avg
Panel avg: 122d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

KTT Device Classification - Class 2, Special Controls

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 287
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K033763.
3.5 MM LCP DISTAL HUMERUS SYSTEM
K033995 · Synthes (Usa) · Mar 2004
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K033476 · Howmedica Osteonics Corp. · Jan 2004
SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM
K033556 · Synthes (Usa) · Jan 2004
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
K033635 · Ebi, L.P. · Dec 2003
SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS
K033411 · Synthes (Usa) · Nov 2003
SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES
K033158 · Synthes (Usa) · Nov 2003