Cleared Special

K040356 - KOMPRESSOR SCREW SYSTEM

K040356 is an FDA 510(k) clearance for KOMPRESSOR SCREW SYSTEM, manufactured by Kinetikos Medical, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 17-day FDA review.

K040356 · Kinetikos Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
17d
Days
Class 2
Risk

K040356 is an FDA 510(k) clearance for the KOMPRESSOR SCREW SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Kinetikos Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on March 1, 2004 after a review of 17 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 Kinetikos Medical, Inc. devices

FDA 510(k) Submission Details - K040356

510(k) Number K040356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2004
Decision Date March 01, 2004
Days to Decision 17 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
105d faster than avg
Panel avg: 122d · This submission: 17d
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 741
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K040356.
HERCULON SOFT TISSUE REATTACHMENT SYSTEM
K040594 · United States Surgical, A Division of Tyco Healthc · Mar 2004
BILOK ST SCREW
K033792 · Biocomposites, Ltd. · Mar 2004
SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS
K033975 · Synthes (Usa) · Mar 2004
ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM
K033639 · Acumed, LLC · Jan 2004
BIOANCHOR WITH DISPOSABLE DRIVER
K033804 · Linvatec Corp. · Dec 2003
LORENZ STERNAL CLOSURE SYSTEM
K033740 · Walter Lorenz Surgical, Inc. · Dec 2003