Cleared Special

K053038 - HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM

K053038 is an FDA 510(k) clearance for HOFFMANN II COMPACT MRI EXTERNAL FIXATI..., manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Special 510(k) pathway after a 26-day FDA review.

K053038 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
26d
Days
Class 2
Risk

K053038 is an FDA 510(k) clearance for the HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on November 22, 2005 after a review of 26 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 Howmedica Osteonics Corp. devices

FDA 510(k) Submission Details - K053038

510(k) Number K053038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2005
Decision Date November 22, 2005
Days to Decision 26 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
96d faster than avg
Panel avg: 122d · This submission: 26d
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 359
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K053038.
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
K053051 · Vanguard Medical Concepts, Inc. · Dec 2005
HOFFMANN II ROD TO WIRE COUPLING
K053349 · Howmedica Osteonics Corp. · Dec 2005
VILEX X-FIX
K052196 · Vilex, Inc. · Nov 2005
EXTERNAL FIXATION
K052605 · Gexfix USA, Inc. · Nov 2005
FRAGMENT SPECIFIC FIXATOR
K052498 · David J. Slutsky MD · Oct 2005
REPROCESSED EXTERNAL FIXATION DEVICE
K051957 · Sterilemed, Inc. · Sep 2005