# K962224: Select Shoulder Concentric Humeral Head Components

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics Orthopedics
- Decided: Aug 28, 1996 after 79 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.
77 later devices descend from it; 1 cites it directly.
0 of 78 devices 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/Biomet 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

## Most influential descendants
- K992525: Acumed Modular Shoulder System (2000), 76 descendants of its own
- K101263: Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System - Finned Humeral Bodies, (2011), 38 descendants of its own
- K100858: Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral Bodies, (2010), 37 descendants of its own
- K111097: Humelock Cemented Shoulder Prosthesis (2011), 34 descendants of its own
- K110847: SMR Shoulder System - Cta Humeral Heads (2011), 34 descendants of its own

Source page: https://510kreport.com/device/K962224
Methodology: https://510kreport.com/methodology