Cleared Traditional

K905014 - AMSET PLD SYSTEM

K905014 is an FDA 510(k) clearance for AMSET PLD SYSTEM, manufactured by Advanced Med/Surg, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K905014 · Advanced Med/Surg, Inc. · Orthopedic device
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Apr 1991
Decision
146d
Days
Class 2
Risk

K905014 is an FDA 510(k) clearance for the AMSET PLD SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Advanced Med/Surg, Inc. (Hayward, US). The FDA issued a Cleared decision on April 1, 1991 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - 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 - K905014

510(k) Number K905014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1990
Decision Date April 01, 1991
Days to Decision 146 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 122d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - HRX Arthroscope

All 553
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K905014.
STRYKER ARTHROSCOPIC INFUSION PUMP
K910858 · Stryker Corp. · May 1991
FLEXMEDICS MALLEABLE CANNULA
K910674 · Flexmedics · Apr 1991
MICROSURGICAL INSTRUMENTS
K911300 · Danek Medical, Inc. · Apr 1991
MOTOR DRIVEN EXTIRPATION INSTRUMENTS
K904859 · Aesculap, Inc. · Mar 1991
ARTHROSCOPIC SURGICAL BLADE
K904284 · Smith & Nephew Dyonics, Inc. · Dec 1990
POWERCUT SURGICAL SYSTEM, BLADES, AND ACCESSORIES
K904720 · Baxter Healthcare Corp · Oct 1990