Cleared Traditional

K030368 - KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW

K030368 is an FDA 510(k) clearance for KARL STORZ MEGAFIX-T TITANIUM INTERFERE..., manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K030368 · KARL STORZ Endoscopy-America, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
44d
Days
Class 2
Risk

K030368 is an FDA 510(k) clearance for the KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on March 20, 2003 after a review of 44 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.

FDA 510(k) Submission Details - K030368

510(k) Number K030368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2003
Decision Date March 20, 2003
Days to Decision 44 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
78d faster than avg
Panel avg: 122d · This submission: 44d
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 1069
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K030368.
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K023192 · Stryker Endoscopy · Mar 2003
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K030706 · Ebi, L.P. · Mar 2003
MICROFIX QUICKANCHOR PLUS
K024115 · Mitek Worldwide · Mar 2003
STRYKER XCEL ANCHOR SYSTEM
K023013 · Stryker Endoscopy · Feb 2003
K030368 · KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW
Download PDF FDA Summary KARL STORZ Endoscopy-…