# K140652: Porous Coated Comprehensive Fracture Stems

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Jul 3, 2014 after 111 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- 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: 5 generations back to K800494 (1980). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 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 5.
- K060692: Comprehensive Primary Shoulder Stems, Biomet Manufacturing Corp (2006) Summary page 5.
- K874643: Kirschner Neer-Iii Modular Proximal Humerus, Kirschner Medical Corp. (1988) Summary page 5.

## Indications for use
The Porous Coated Comprehensive® Fracture Stems are indicated 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 arthropathy, where other methods of treatment may not be suitable or may be inadequate. 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). The Comprehensive® Fracture Stems are intended for use with the Bio-Modular Humeral Heads and glenoid components and Versa-Dial Humeral Heads. The Comprehensive™ Humeral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive™ Fracture Stem. The Comprehensive™ Shoulder Stems (Fracture, Primary and Revision) are intended for use with the Bio-Modular™ Humeral Heads and glenoid components and Versa-Dial™ Humeral Heads. 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. When a humeral stem and/or Versa-Dial™ Taper Adapter is being used for a reverse shoulder application, the user should refer to the package insert (01-50-0903) continued with the reverse shoulder components for additional information, including alternate indications.

Source page: https://510kreport.com/device/K140652
Methodology: https://510kreport.com/methodology