# K962289: Select Shoulder Cocr Humeral Stem Component

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics Orthopedics
- Decided: Aug 29, 1996 after 76 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. The FDA summary names its predicate without a 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 Integrated Shoulder System: named in the summary without a submission number
- (no number) 3M/Orthomet Neer II Shoulder System: named in the summary without a submission number
- (no number) Smith & Nephew Richards Cofield Shoulder: named in the summary without a submission number

## Indications for use
The Select Shoulder Humeral Stem is a metallic humeral component manufactured from cobalt chrome alloy (CoCrMo) and is intended for use either with or without bone cement in hemiarthroplasty.

Source page: https://510kreport.com/device/K962289
Methodology: https://510kreport.com/methodology