# K961571: Cocr BI-Angular Humeral Component

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Aug 5, 1996 after 104 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
Longest line of descent: 1 generation back to K872454 (1987). 3 ancestors in all.
147 later devices descend from it; 1 cites it directly.
0 of 151 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940537: Kirschner (R) Modular II-C (TM) Total Shoulder System, Kirschner Medical Corp. (1995) Summary page 2.
- K873073: Kirschner Neer-Iii Proximal Humerus, Kirschner Medical Corp. (1987) Summary page 2.
- K872454: Biomet Modular Shoulder Prosthesis, Biomet, Inc. (1987) Summary page 2.

## Most influential descendants
- K023063: Comprehensive Humeral Fracture System (2002), 146 descendants of its own
- K060692: Comprehensive Primary Shoulder Stems (2006), 138 descendants of its own
- K102924: Aequalis Ascend Modular Anatomic Shoulder System (2011), 110 descendants of its own
- K110599: Aequalis Ascend Modular Reverse Shoulder System (2011), 108 descendants of its own
- K120794: Ascend Shoulder System (2012), 98 descendants of its own

Source page: https://510kreport.com/device/K961571
Methodology: https://510kreport.com/methodology