# K032895: BI-Angular Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Nov 20, 2003 after 64 days
- Product code: MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K800494 (1980). 16 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030710: Bio-Modular Shoulder System, Biomet, Inc. (2003)
- K925613: Proximal Humeral Replacement System, Biomet, Inc. (1994) Summary page 1.

## Most influential descendants
- K042321: Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head (2005), 9 descendants of its own
- K111746: Comprehensive Segmental Revision System (SRS) (2011), 7 descendants of its own
- K143659: Equinoxe Mega Prosthesis (2015), 5 descendants of its own
- K153398: Comprehensive SRS/Nexel Elbow (2016), 3 descendants of its own
- K173411: Comprehensive Segmental Revision System (SRS) (2018), 2 descendants of its own

## Indications for use
1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis 2) Rheumatoid arthritis 3) Revision where other devices or treatments have failed 4) Correction of functional deformity 5) Fractures of the proximal humerus, where other methods of treatment are deemed inadequate 6) Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate Devices with surface coatings are indicated for cemented or uncemented biological fixation application. Non-coated (InterlokQ) devices and all polyethylene components are indicated for cemented application only.

Source page: https://510kreport.com/device/K032895
Methodology: https://510kreport.com/methodology