# K043100: Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid Components

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Feb 17, 2005 after 100 days
- Product code: MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3670
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K800494 (1980). 15 ancestors in all.
176 later devices descend from it; 1 cites it directly.
1 of 192 devices in its family (counting itself) has a Class I recall.

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

## Most influential descendants
- K072804: Comprehensive RS Shoulder System (2007), 175 descendants of its own
- K080642: Comprehensive Reverse Shoulder (2008), 172 descendants of its own
- K110599: Aequalis Ascend Modular Reverse Shoulder System (2011), 108 descendants of its own
- K112615: Aequalis Ascend Modular Reverse Shoulder System (2011), 97 descendants of its own
- K122698: Aequalis Ascend Flex Shoulder System (2013), 96 descendants of its own

## Recalls of this device
- Aug 21, 2019 · Class II · Z-0533-2020: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

## Indications for use
Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, Rheumatoid arthritis, Revision where other devices or treatments have failed, Correction of functional deformity, Fractures of the proximal humerus, where other methods of treatment are deemed inadequate, Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate. Humeral components with a Macrobond surface coating are indicated for either cemented or uncemented press-fit applications. Humeral/glenoid components with a porous coated surface coating are indicated for either cemented or uncemented biological fixation applications (Metal backed glenoid components offer optional screw fixation). Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications (Metal backed glenoid components offer optional screw fixation). Humeral components with a non-coated (Interlok) surface are indicated for cemented application only. Polyethylene glenoid components not attached to a metal back are indicated for cemented application only. The Comprehensive Humeral Fracture Stem is intended for use with the Bio-Modular humeral heads and glenoid components. The Versa-Dial Humeral Head Prosthesis is intended for use only with the Comprehensive Humeral Fracture Stem and the glenoid components of the Bio-Modular Shoulder System.

Source page: https://510kreport.com/device/K043100
Methodology: https://510kreport.com/methodology