Cleared Abbreviated

K982418 - BUECHEL-PAPPAS MODULAR SALVAGE STEM (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K982418 · Endotec, Inc. · Orthopedic device
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Apr 1999
Decision
290d
Days
Class 3
Risk

K982418 is an FDA 510(k) clearance for the BUECHEL-PAPPAS MODULAR SALVAGE STEM. Classified as Prosthesis, Shoulder, Humeral (bipolar Hemi-shoulder) Metal/polymer, Cemented Or Uncemented (product code MJT), Class III - Premarket Approval.

Submitted by Endotec, Inc. (South Orange, US). The FDA issued a Cleared decision on April 29, 1999 after a review of 290 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. 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 Endotec, Inc. devices

Submission Details

510(k) Number K982418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1998
Decision Date April 29, 1999
Days to Decision 290 days
Submission Type Abbreviated
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 122d · This submission: 290d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code MJT Prosthesis, Shoulder, Humeral (bipolar Hemi-shoulder) Metal/polymer, Cemented Or Uncemented
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.