# K161192: Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System

- Pathway: 510(k) (Special)
- Applicant: Zimmer GmbH
- Decided: Jul 8, 2016 after 72 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K921308 (1994). 22 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043356: Wagner SL Revision Stem Lateral, Zimmer Austin, Inc. (2005) Summary page 5.
- K113556: Wagner Cone Prosthesis System, Zimmer GmbH (2012) Summary page 5.

## Most influential descendants
- 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
- K191781: Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System (2019), 1 descendant of its own

## 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/K161192
Methodology: https://510kreport.com/methodology