# K060716: Versa-Dial Humeral Head Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Jun 12, 2006 after 87 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: 5 generations back to K800494 (1980). 25 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040610: Versa-Dial Humeral Head, Biomet Manufacturing, Inc. (2004) Summary page 1.
- K002998: Biomet BI-Polar Shoulder System, Biomet, Inc. (2000) Summary page 1.

## Cited in the summary but kept off the family tree
- K030710: Bio-Modular Shoulder System, Biomet, Inc. (2003). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K202716: Ignite Anatomic Shoulder System (2021), 13 descendants of its own
- K212737: INHANCE™ Reverse Shoulder System (2022), 9 descendants of its own
- K203108: Ignite Stemless Anatomic Shoulder System (2021), 3 descendants of its own
- K250644: MSS - Monobloc stem (2026), 1 descendant of its own
- K241817: InSet Total Shoulder System (2025), 1 descendant of its own

## Indications for use
The Versa-Dial Humeral Head Prosthesis is intended for: 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 tear 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, and the glenoid components of the Bio-Modular Shoulder System. The device is a single-use implant.

Source page: https://510kreport.com/device/K060716
Methodology: https://510kreport.com/methodology