# K991603: Grit Blasted Humeral Stem

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Jun 29, 1999 after 50 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- 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. The FDA summary names its predicate without a number.
- (no number) Total Shoulder System (Encore): named in the summary without a submission number

## Indications for use
This humeral stem will be used as part of a total shoulder system intended for treatment of patients who are candidates for total shoulder arthroplasty because the natural humeral head and/or glenoid has been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or proximal humeral fracture, and revision arthroplasty where bone loss is minimal. The humeral stem may be used with or without bone cement. These devices are intended to aid the surgeon in relieving the patient of shoulder pain and restoring shoulder motion.

Source page: https://510kreport.com/device/K991603
Methodology: https://510kreport.com/methodology