# K191781: Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System

- Pathway: 510(k) (Special)
- Applicant: Zimmer GmbH
- Decided: Aug 6, 2019 after 35 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: 8 generations back to K921308 (1994). 23 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 25 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.
- K161192: Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System, Zimmer GmbH (2016) Summary page 5.
- K113556: Wagner Cone Prosthesis System, Zimmer GmbH (2012) Summary page 5.

## Most influential descendants
- K200112: Zimmer Hip Joint Replacement (2020), 0 descendants 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. • Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure. • Revision of previously failed hip arthroplasty

Source page: https://510kreport.com/device/K191781
Methodology: https://510kreport.com/methodology