# K040610: Versa-Dial Humeral Head

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing, Inc.
- Decided: Jun 4, 2004 after 88 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- 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). 24 ancestors in all.
17 later devices descend from it; 1 cites 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)
- K023063: Comprehensive Humeral Fracture System, Biomet Orthopedics, Inc. (2002) Summary page 1.
- K030710: Bio-Modular Shoulder System, Biomet, Inc. (2003) Summary page 1.

## Most influential descendants
- K060716: Versa-Dial Humeral Head Prosthesis (2006), 16 descendants of its own
- 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

## 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 tear arthropathy, where other methods of treatment may not be suitable or may be inadequate. The Versa-Dial TM Humeral Head Prosthesis is intended for use with the Comprehensive Humeral Fracture Stem for either cemented or uncemented (press-fit) use. The Versa-Dial TM Humeral Head Prosthesis is intended for use with the glenoid components of the Bio-Modular Shoulder System, either all polyethylene for cemented use or metal backed for uncemented (biological fixation with optional screw fixation) use.

Source page: https://510kreport.com/device/K040610
Methodology: https://510kreport.com/methodology