# K962315: Select Shoulder Cocr Humeral Stem Component

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics Orthopedics
- Decided: Sep 3, 1996 after 78 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.
335 later devices descend from it; 2 cite it directly.
1 of 336 devices in its family (counting itself) has 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 I 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

## Most influential descendants
- K041339: Aequalis Shoulder System (2004), 259 descendants of its own
- K043077: Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System (2004), 258 descendants of its own
- K060209: Aequalis Shoulder Fracture System & Aequalis Shoulder System (2006), 257 descendants of its own
- K982981: New Zimmer Shoulder System (1998), 235 descendants of its own
- K041549: Zimmer Trabecular Metal Humeral Stem (2004), 218 descendants of its own

## Indications for use
The humeral component is intended for use with bone cement in total shoulder arthroplasty.

Source page: https://510kreport.com/device/K962315
Methodology: https://510kreport.com/methodology