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Buechel-Pappas Modular Salvage Stem

FDA 510(k)

Class III (US FDA 510(k))

510(k) K982418

by Endotec, Inc.

Identifiers

510(k) Number
K982418 FDA 510(k)
FDA Product Code
MJT FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Advisory Committee
Unknown FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Buechel-Pappas Modular Salvage Stem is a Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, designed for modular reconstruction of the humeral component in shoulder arthroplasty. It is intended for use in cemented or uncemented fixation, providing structural support to restore function in severely damaged or painful shoulder joints.

This device is supplied as a modular system for surgical use in orthopedic settings, with components tailored for specific anatomical requirements. It is regulated under FDA 510(k) clearance (K982418) as a Class III device, adhering to strict manufacturing and performance standards. The modular design allows for customization to address individual patient anatomy, ensuring compatibility with existing shoulder replacement systems.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K982418 FDA 510 (k) - BUECHEL-PAPPAS MODULAR SALVAGE STEM, BUECHEL-PAPPAS MODULAR SALVAGE STEM (K982418) — FDA 510 (k) | Innolitics, Buechel-pappas Modular Salvage Stem 510 (k) FDA Premarket Notification ..., PDF K982418 - Buechel-pappas Modular Salvage Stem

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Endotec, Inc.

Sources (1)

  • FDA 510(k) K982418 24 fields · synced Sep 18, 2026