Cleared Traditional

K911398 - ASNIS 2 SMALL DIAMETER CANNULATED SCREW...

K911398 is the FDA 510(k) clearance for ASNIS 2 SMALL DIAMETER CANNULATED SCREW... by Howmedica Corp.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K911398 · Howmedica Corp. · Orthopedic device
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Jun 1991
Decision
90d
Days
Class 2
Risk

K911398 is an FDA 510(k) clearance for the ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on June 27, 1991 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Howmedica Corp. devices

Submission Details

510(k) Number K911398 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 29, 1991
Decision Date June 27, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 563
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K911398.
AESCULAP TITANIUM BONE SCREWS
K913415 · Aesculap, Inc. · Oct 1991
HUENE FIXATION SCREW
K910193 · Acu Med, Inc. · Aug 1991
UNIVERSAL COMPRESSION SCREW
K904809 · Howmedica Corp. · Jun 1991
CANCELLOUS SCREW
K903253 · Onyx Medical Corp. · Aug 1990
U.S. TYPE CRUCIATE SLOT BONE SCREW
K903254 · Onyx Medical Corp. · Aug 1990
CORTICAL BONE SCREW (EUROPEAN STYLE)
K903255 · Onyx Medical Corp. · Aug 1990