# K953689: Wagner Revision Stem (Modification)

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics Orthopedics
- Decided: Nov 29, 1995 after 121 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
No predicates in its family tree.
12 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K043356: Wagner SL Revision Stem Lateral (2005), 11 descendants of its own
- 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

Source page: https://510kreport.com/device/K953689
Methodology: https://510kreport.com/methodology