# K193180: Alliance Augmented Glenoid

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Feb 24, 2020 after 98 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: 6 generations back to K800494 (1980). 28 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191814: Alliance Glenoid, Zimmer, Inc. (2019) Summary page 4.

## Most influential descendants
- K233148: Augment Off-Axis Instrument System (2024), 2 descendants of its own
- K241043: Augment Off-Axis Instrument System (2024), 1 descendant of its own
- K261683: Augment Off-Axis Instrument System (2026), 0 descendants of its own

## Indications for use
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. 5. Difficult clinical management problems, where other methods of treatment may not be suitable or may be inadequate. Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure. The Alliance Monoblock glenoid components are indicated for cemented application only. The Alliance Modular Glenoid components are intended to be implanted with bone cement. The TM and porous posts may be inserted without bone cement.

Source page: https://510kreport.com/device/K193180
Methodology: https://510kreport.com/methodology