# K982886: Oti Modular Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Osteoimplant Technology, Inc.
- Decided: Oct 5, 1998 after 49 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Prosthetic replacement with the OTI Modular Shoulder System (Hemi humeral component) may be indicated to relieve severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the shoulder joint; non-union in humeral head fractures of long duration; avascular necrosis of the humeral hcad, traumatic fractures of the humerus and/ or other difficult clinical management problems.

Source page: https://510kreport.com/device/K982886
Methodology: https://510kreport.com/methodology