# K140390: Titanium Versa-Dial Humeral Head Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Sep 10, 2014 after 208 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: 6 generations back to K800494 (1980). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060716: Versa-Dial Humeral Head Prosthesis, Biomet Manufacturing Corp (2006) Summary page 4.
- K915596: Biomodular Shoulder Humeral Head W/ Ionguard, Biomet, Inc. (1992) Summary page 4.
- K030710: Bio-Modular Shoulder System, Biomet, Inc. (2003) Summary page 4.

## Most influential descendants
- K182799: Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads (2019), 0 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. 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). Polyethylene glenoid components not attached to a metal back are indicated for cemented application only. The Versa-Dial Humeral Head Prosthesis is intended for use only with the Comprehensive Shoulder Stems (Fracture, Primary and Revision), the Bio-Modular Shoulder Stems, the glenoid components of the Bio-Modular Shoulder System, and the glenoid components of the Comprehensive Shoulder System. The Titanium Versa-Dial Humeral Head Prosthesis are indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy.

Source page: https://510kreport.com/device/K140390
Methodology: https://510kreport.com/methodology