Cleared Traditional

K911398 - ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM

K911398 is an FDA 510(k) clearance for ASNIS 2 SMALL DIAMETER CANNULATED SCREW..., manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K911398

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.

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 923
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
ACE 3.5MM CORTICAL BONE SCREW
K905048 · Ace Medical Co. · Jan 1991
U.S. TYPE CRUCIATE SLOT BONE SCREW
K905333 · O'Tec Corp. · Jan 1991
CORTICAL BONE SCREW (EUROPEAN STYLE)
K905357 · O'Tec Corp. · Jan 1991