Cleared Traditional

K981451 - ARGOMEDICAL BIPOLAR SYSTEM

K981451 is an FDA 510(k) clearance for ARGOMEDICAL BIPOLAR SYSTEM, manufactured by Stelkast Company. The device is a Class 2 Orthopedic device with product code KWL cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K981451 · Stelkast Company · Orthopedic device
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Aug 1998
Decision
121d
Days
Class 2
Risk

K981451 is an FDA 510(k) clearance for the ARGOMEDICAL BIPOLAR SYSTEM. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Stelkast Company (Pittsburgh, US). The FDA issued a Cleared decision on August 21, 1998 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 Stelkast Company devices

FDA 510(k) Submission Details - K981451

510(k) Number K981451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1998
Decision Date August 21, 1998
Days to Decision 121 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 122d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWL Device Classification - Class 2, Special Controls

Product Code KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - KWL Prosthesis, Hip, Hemi-, Femoral, Metal

All 92
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K981451.
PLUS FRACTURE HEAD PROSTHESIS
K990309 · Plus Orthopedics · Mar 1999
OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE
K984585 · Osteonics Corp. · Feb 1999
THE NEW BIO-MOORE ENDO HEADS
K984028 · Biomet, Inc. · Jan 1999
OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM
K974807 · Osteonics Corp. · Mar 1998
FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES
K973614 · Encore Orthopedics, Inc. · Dec 1997
ULTIMA TPS CEMENTED STEM
K965198 · Johnson & Johnson International · Jul 1997