Cleared Traditional

K911768 - AMSET(TM) BONE SCREW

K911768 is an FDA 510(k) clearance for AMSET(TM) BONE SCREW, manufactured by Advanced Med/Surg, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 168-day FDA review.

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

FDA 510(k) Submission Details - K911768

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.

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 993
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K911768.
ACE CORTICAL BONE SCREW
K912598 · Ace Medical Co. · Nov 1991
MAKAR MINI CANNULATED CANCELLOUS SCREWS
K912021 · Instrument Makar, Inc. · Nov 1991
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
ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM
K911398 · Howmedica Corp. · Jun 1991