Seviin Surface Replacement Shoulder
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K130635 FDA 510(k)
- FDA Product Code
- HSD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3690 FDA 510(k)
- Regulation Number
- 888.3690 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Seviin Surface Replacement Shoulder is a shoulder arthroplasty device designed for partial joint replacement, specifically addressing glenohumeral arthritis. It replaces the damaged articular surfaces of the humeral head and glenoid cavity to restore joint function and alleviate pain in affected patients.
This device is intended for surgical use in orthopedic settings and has received FDA 510(k) clearance under the Traditional pathway. Supplied as a modular system, it is intended for single-use and requires sterile handling. The product is categorized under the product code HSD and was reviewed by the Orthopedic (OR) Advisory Committee.
Frequently asked questions
What specific type of shoulder arthritis is the Seviin Surface Replacement Shoulder designed to treat, and how does it differ from a full shoulder replacement?
The Seviin Surface Replacement Shoulder is designed for partial joint replacement, specifically targeting glenohumeral arthritis—the degenerative joint disease affecting the ball-and-socket connection between the humeral head and glenoid cavity. Unlike a total shoulder arthroplasty, which replaces the entire joint, this device only replaces the damaged articular surfaces of the humeral head and glenoid, preserving more of the patient’s natural anatomy while restoring function and reducing pain.
Is the Seviin Surface Replacement Shoulder intended for reuse in multiple surgeries, or is it meant to be used once and then discarded?
The Seviin Surface Replacement Shoulder is supplied as a single-use device, meaning it is intended for one surgical procedure only. Sterile handling is required, and reuse is not recommended or supported by the manufacturer to ensure patient safety and device performance.
How is the Seviin Surface Replacement Shoulder supplied, and does it come in different sizes or configurations?
The device is supplied as a modular system, which implies it may include interchangeable components to accommodate varying patient anatomies. While the exact sizing options aren’t detailed here, modular designs like this typically offer multiple sizes or configurations for the humeral head and glenoid components to ensure a proper fit during surgery. For precise sizing details, refer to the manufacturer’s surgical technique guide or packaging.
What precautions should be taken when storing the Seviin Surface Replacement Shoulder before use, given its sterile requirements?
Since the device requires sterile handling, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging is likely designed to maintain sterility until the time of use, so avoid opening or exposing it to contamination before surgery. Always follow the manufacturer’s storage instructions provided with the device.
What was the regulatory pathway used for FDA clearance of the Seviin Surface Replacement Shoulder, and which advisory committee reviewed it?
The Seviin Surface Replacement Shoulder received FDA 510(k) clearance under the Traditional pathway, meaning it was determined to be substantially equivalent to a legally marketed device already on the market. The review was conducted by the Orthopedic (OR) Advisory Committee, which provides expert input on orthopedic devices before clearance decisions. The product code assigned is HSD, indicating its classification as a shoulder device.
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: About - Ingen Orthopedics, Seviin Surface Replacement Shoulder - Ingen Orthopedics | FDA Evidence ..., About - Ingen Orthopedics, SEVIIN SURFACE REPLACEMENT SHOULDER (K130635) — FDA 510 (k) - Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130635 | Class II | Active |
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Manufacturer
- Manufacturer
- Ingen Orthopedics, LLC
Sources (1)
- FDA 510(k) K130635 24 fields · synced Sep 19, 2026