Cleared Traditional

K024233 - KOMPRESSOR SCREW SYSTEM

K024233 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 Traditional 510(k) pathway after a 45-day FDA review.

K024233 · Kinetikos Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
45d
Days
Class 2
Risk

K024233 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 February 6, 2003 after a review of 45 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kinetikos Medical, Inc. devices

FDA 510(k) Submission Details - K024233

510(k) Number K024233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2002
Decision Date February 06, 2003
Days to Decision 45 days
Submission Type Traditional
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
77d faster than avg
Panel avg: 122d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K024233.
KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW
K030368 · KARL STORZ Endoscopy-America, Inc. · Mar 2003
EBI DYNAFIX COMPRESSION BONE SCREW
K030706 · Ebi, L.P. · Mar 2003
STRYKER XCEL ANCHOR SYSTEM
K023013 · Stryker Endoscopy · Feb 2003
PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM
K024086 · Biomet Orthopedics, Inc. · Jan 2003
MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM
K024060 · Howmedica Osteonics Corp. · Dec 2002
AAP CANNULATED SCREWS
K021233 · Aap Implantate AG · Dec 2002