510(k) · Cleared
ClearedWagner SL Revision Stem Lateral
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Austin, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Apr 18, 2005 as substantially equivalent to K953689 (Intermedics Orthopedics, 1995) after a 133-day review. Its family tree reaches back 1 generation to 1995. 11 later devices descend from it.
- Decided
- Apr 18, 2005
- Review
- 133 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953689 (1995). 11 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK953689 Wagner Revision Stem (Modification)Intermedics Orthopedics · 1995
- This deviceK043356 Wagner SL Revision Stem LateralZimmer Austin, Inc. · 2005
- Descendant · cites it directly · 8 of its ownK161192 Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH · 2016
- Descendant · 2 generations on · 5 of its ownK170690 M-Vizion Femoral Revision SystemMedacta International S.A. · 2017
- Descendant · 3 generations on · 4 of its ownK191816 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2020
- Descendant · 4 generations on · 3 of its ownK201471 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2021
- Descendant · cites it directly · 1 of its ownK212327 M-Vizion MonoblocMedacta International S.A. · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH · 2016 · cites it directly8descendants
- K170690M-Vizion Femoral Revision SystemMedacta International S.A. · 2017 · 2 generations on5descendants
- K191816M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2020 · 3 generations on4descendants
- K201471M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2021 · 4 generations on3descendants
- K212327M-Vizion MonoblocMedacta International S.A. · 2022 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953689 | Wagner Revision Stem (Modification) | Intermedics Orthopedics | 1995 | — |
| 0 (this device) | K043356 | Wagner SL Revision Stem Lateral | Zimmer Austin, Inc. | 2005 | — |
| +1 | K161192 | Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System | Zimmer GmbH | 2016 | — |
| +2 | K170690 | M-Vizion Femoral Revision System | Medacta International S.A. | 2017 | — |
| +3 | K191816 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2020 | — |
| +4 | K201471 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2021 | — |
| +1 | K212327 | M-Vizion Monobloc | Medacta International S.A. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LZO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K953689 | Wagner Revision Stem (Modification)Summary page 1…LZO) are Class IIper 21 CFR §888.3353, reviewed by the Orthopedic Devices panel. PREDICATE DEVICE: Wagner SL Revision Stem (K953689) DEVICE DESCRIPTION: Both the existing Wagner SL Revision Stem and the proposed Wagner SL Revision Stem Lateral are manufactured… | 1995 |
What descends from it? (11)
See all 114 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043356 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043356: Wagner SL Revision Stem Lateral.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043356
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026