# K130635: Seviin Surface Replacement Shoulder

- Pathway: 510(k) (Traditional)
- Applicant: Ingen Orthopedics, LLC
- Decided: Aug 26, 2013 after 168 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K800494 (1980). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010657: Copeland MB Resurfacing Humeral Heads, Biomet Manufacturing, Inc. (2001) Summary page 1.
- K062661: Aequalis Resurfacing Head, Tornier (2006) Summary page 1.

## Indications for use
The SEVIIN Surface Replacement Shoulder is indicated for hemi or total shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and there is an intact or reconstructable rotator cuff. Hemi or total shoulder replacement is indicated to relieve severe pain or significant disability caused by: * Rheumatoid arthritis * Non-inflammatory degenerative joint disease (osteoarthritis and avascular necrosis) * Correction of functional deformity * Humeral head fractures * Traumatic arthritis The SEVIIN Resurfacing Humeral Heads are intended for cemented and uncemented applications. The glenoid components, when used, are intended for cemented use only.

Source page: https://510kreport.com/device/K130635
Methodology: https://510kreport.com/methodology