Cleared Traditional

AMSET(TM) BONE SCREW (K911768) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K911768 · Advanced Med/Surg, Inc. · Orthopedic device
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Oct 1991
Decision
168d
Days
Class 2
Risk

K911768 is an FDA 510(k) clearance for the AMSET(TM) BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Advanced Med/Surg, Inc. (Hayward, US). The FDA issued a Cleared decision on October 4, 1991 after a review of 168 days - an extended review 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: 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 Advanced Med/Surg, Inc. devices

Submission Details

510(k) Number K911768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1991
Decision Date October 04, 1991
Days to Decision 168 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 122d · This submission: 168d
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 405
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K911768.
UNIVERSAL COMPRESION SCREW
K915124 · Howmedica Corp. · Feb 1992
M. KUROSAKA(TM) FIXATION SCREW
K913210 · Depuy, Inc. · Jan 1992
AESCULAP TITANIUM BONE SCREWS
K913415 · Aesculap, Inc. · Oct 1991
UNIVERSAL COMPRESSION SCREW
K904809 · Howmedica Corp. · Jun 1991
ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM
K911398 · Howmedica Corp. · Jun 1991
EXACTECH BONE SCREW
K896601 · Exactech, Inc. · Dec 1989