# K971715: Select Shoulder Offset Humeral Head Components

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Aug 7, 1997 after 90 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- 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) Tornier Aequalis Shoulder System: named in the summary without a submission number
- (no number) DePuy Global Total Shoulder System: named in the summary without a submission number
- (no number) Biomet Bio-Modular Total Shoulder: named in the summary without a submission number
- (no number) Zimmer Fenlin Total Shoulder: named in the summary without a submission number
- (no number) Kirschner Modular Shoulder System: named in the summary without a submission number
- (no number) 3M/Orthomet Modular Neer II Shoulder System: named in the summary without a submission number
- (no number) Encore Foundation Shoulder System: named in the summary without a submission number

## Indications for use
The Select Shoulder Offset Humeral Heads, when used with one of the Select Shoulder Humeral Stems and Glenoid Components (if applicable), are intended for use in treatment of the following: 1. Patient conditions, including but not limited to, noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis or post-traumatic arthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. 2. Complex acute fractures, fracture-dislocations of the humeral head, malunion or non-union of a small osteoporotic head fragment, chronic, recurrent or acute dislocation with loss of humeral head cartilage, or large impression fractures. 3. Those patients with failed previous surgery where pain, deformity, or dysfunction persists. 4. Failed previous surgery, including joint reconstruction, internal fixation, nonunion of the humeral neck, arthrodesis or hemiarthroplasty. 5. Cuff tear arthropathy. 6. Avascular necrosis or osteonecrosis of the humeral head. 7. Tumor resection.

Source page: https://510kreport.com/device/K971715
Methodology: https://510kreport.com/methodology