# K113556: Wagner Cone Prosthesis System

- Pathway: 510(k) (Special)
- Applicant: Zimmer GmbH
- Decided: Feb 17, 2012 after 78 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- 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: 6 generations back to K921308 (1994). 19 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032380: Wagner Cone Prosthesis, Centerpulse Orthopedics, Inc. (2003) Summary page 2.
- K042249: CLS Spotorno Stem, Zimmer Austin, Inc. (2004) Summary page 2.

## Most influential descendants
- K161192: Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System (2016), 8 descendants of its own
- K170690: M-Vizion Femoral Revision System (2017), 5 descendants of its own
- K191816: M-Vizion Femoral Revision System Extension (2020), 4 descendants of its own
- K201471: M-Vizion Femoral Revision System Extension (2021), 3 descendants of its own
- K212327: M-Vizion Monobloc (2022), 1 descendant of its own

## Recalls of this device
- Sep 4, 2012 · Class II · Z-0221-2013: Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints 

## Indications for use
Noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis. Failed previous surgery where pain, deformity, or dysfunction persists. Revision of previously failed hip arthroplasty.

Source page: https://510kreport.com/device/K113556
Methodology: https://510kreport.com/methodology