# K043356: Wagner SL Revision Stem Lateral

- Pathway: 510(k) (Special)
- Applicant: Zimmer Austin, Inc.
- Decided: Apr 18, 2005 after 133 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: 1 generation back to K953689 (1995). 1 ancestor in all.
11 later devices descend from it; 4 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)
- K953689: Wagner Revision Stem (Modification), Intermedics Orthopedics (1995) Summary page 1.

## 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

## Indications for use
The Wagner SL Revision Stem Lateral is intended for prosthetic replacement of the proximal portion of the femur during total hip arthroplasty. It is intended for press-fit application. Specific diagnostic indications include: * Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis; and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. * Patients with failed previous surgery where pain, deformity, or dysfunction persists. * Revision of previously failed hip arthroplasty.

Source page: https://510kreport.com/device/K043356
Methodology: https://510kreport.com/methodology