Cleared Traditional

K931538 - AMSET(TM) CANNULATED BONE SCREW

K931538 is an FDA 510(k) clearance for AMSET(TM) CANNULATED 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 401-day FDA review.

K931538 · Advanced Med/Surg, Inc. · Orthopedic device
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May 1994
Decision
401d
Days
Class 2
Risk

K931538 is an FDA 510(k) clearance for the AMSET(TM) CANNULATED 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 May 4, 1994 after a review of 401 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Advanced Med/Surg, Inc. devices

FDA 510(k) Submission Details - K931538

510(k) Number K931538 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 29, 1993
Decision Date May 04, 1994
Days to Decision 401 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
279d slower than avg
Panel avg: 122d · This submission: 401d
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 K931538.
ARTHROTEK SET SCREW
K932721 · Biomet, Inc. · Aug 1994
TITANIUM ALLOY BONE SCREWS
K940207 · Aesculap, Inc. · Jul 1994
BIOSCREW ABSORBABLE INTERFERENCE SCREW
K933719 · Linvatec Corp. · May 1994
CANNULATED CANCELLOUS SCREW
K931680 · Onyx Medical Corp. · May 1994
ACE 6.5 MM BONE SCREW
K931652 · Ace Medical Co. · Apr 1994
CANNULATED NAVICULAR SCREW
K931681 · Onyx Medical Corp. · Apr 1994