# K915596: Biomodular Shoulder Humeral Head W/ Ionguard

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Mar 11, 1992 after 89 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.
254 later devices descend from it; 2 cite it directly.
1 of 255 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K030710: Bio-Modular Shoulder System (2003), 253 descendants of its own
- K043100: Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid Components (2005), 176 descendants of its own
- K072804: Comprehensive RS Shoulder System (2007), 175 descendants of its own
- K080642: Comprehensive Reverse Shoulder (2008), 172 descendants of its own
- K060692: Comprehensive Primary Shoulder Stems (2006), 138 descendants of its own

Source page: https://510kreport.com/device/K915596
Methodology: https://510kreport.com/methodology