# K110791: Bigliani / Flatow (R) the Complete Shoulder Solution

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Sep 2, 2011 after 165 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- 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: 2 generations back to K790987 (1979). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982981: New Zimmer Shoulder System, Zimmer, Inc. (1998) Summary page 1.

## Recalls of this device
- Jun 11, 2013 · Class II · Z-1676-2013: The firm is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (00-4301-012-17, lot 62283991) as the stems manufactured under the lot are 14mm x 170mm devices incorrectly 

## Indications for use
Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohiumeral joint; ununited humeral head fractures of long duration; irreducible 3- and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult clinical management problems where artbrodesis or resectional arthroplasty is not acceptable. the assembled humeral component may be used alone for hemarthroplasty or combined with the glenoid component for total shoulder arthroplasty. Humneral heads with heights of 27mm or greater may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional nonconstrained arthroplasty is not acceptable. The humeral component can be implanted either cemented or press-fit while the glenoid component is designed for cemented use only.

Source page: https://510kreport.com/device/K110791
Methodology: https://510kreport.com/methodology