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Seviin Fracture Shoulder

FDA 510(k)

Class II (US FDA 510(k))

510(k) K131277

by Ingen Orthopedics, LLC

Identifiers

510(k) Number
K131277 FDA 510(k)
FDA Product Code
KWS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3660 FDA 510(k)
Regulation Number
888.3660 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Seviin Fracture Shoulder is a hemi or total shoulder prosthesis classified under the nomenclature for orthopedic fracture fixation devices. It is designed to restore function and stability in patients with acute fractures of the proximal humerus, providing structural support to the shoulder joint during the healing process.

This device is supplied as a sterile, single-use orthopedic implant intended for surgical use in orthopedic settings. It is available in specific model versions, including the 107-01-25, and adheres to FDA 510(k) clearance under the traditional review pathway. Compliance with FDA regulations ensures its safety and performance for intended orthopedic applications.

Frequently asked questions

What types of shoulder fractures is the Seviin Fracture Shoulder designed to address, and how does it help during recovery?

The Seviin Fracture Shoulder is specifically designed to restore function and stability in patients with acute fractures of the proximal humerus. It acts as a hemi or total shoulder prosthesis, providing structural support to the shoulder joint while the bone heals. This helps reduce pain, maintain alignment, and improve mobility during the critical healing period.

Is the Seviin Fracture Shoulder reusable, or is it intended for single-use only? How does this affect its sterility?

The Seviin Fracture Shoulder is sterile and intended for single-use only, as explicitly stated in its surgical implant specifications. This ensures patient safety by preventing cross-contamination and maintaining sterile conditions during orthopedic procedures.

What model variations are available for the Seviin Fracture Shoulder, and how might a surgeon choose between them?

The Seviin Fracture Shoulder is available in specific model versions, such as the 107-01-25. While the exact differences between models aren’t detailed here, variations typically account for anatomical differences (e.g., humeral head size, neck-shaft angles) or fracture complexity. A surgeon would select the appropriate model based on the patient’s fracture pattern, bone structure, and surgical goals to ensure proper fit and stability.

How is the Seviin Fracture Shoulder regulated in the U.S., and what does that mean for its safety and use?

The Seviin Fracture Shoulder is cleared by the FDA under the 510(k) pathway, specifically through a traditional review and classified as substantially equivalent to a predicate device. This means it has undergone rigorous evaluation by the FDA to ensure its safety, effectiveness, and performance for its intended use in orthopedic fracture fixation, adhering to strict manufacturing and clinical standards.

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: Instrument Guide | Ingen Orthopedics, PDF Summary - Food and Drug Administration, Ingen SEVIIN® Shoulder System — FDA Class II Medical Device | MedEquip ..., Ingen SEVIIN® Shoulder System - BEUDAMED, Ingen Orthopedics - LinkedIn

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ingen Orthopedics, LLC

Sources (1)

  • FDA 510(k) K131277 24 fields · synced Sep 19, 2026