510(k) · Cleared
ClearedWagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer GmbH · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Jul 8, 2016 as substantially equivalent to K043356 (Zimmer Austin, Inc., 2005) and 1 other predicate after a 72-day review. Its family tree reaches back 7 generations to 1994. 8 later devices descend from it.
- Decided
- Jul 8, 2016
- Review
- 72 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K921308 (1994). 22 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 6 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
- 5 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- 4 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- 3 generations backK022549 Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · Recalled
- 2 generations backK032380 Wagner Cone ProsthesisCenterpulse Orthopedics, Inc. · 2003
- 1 generation backK113556 Wagner Cone Prosthesis SystemZimmer GmbH · 2012 · Recalled
- This deviceK161192 Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH · 2016
- Descendant · cites it directly · 5 of its ownK170690 M-Vizion Femoral Revision SystemMedacta International S.A. · 2017
- Descendant · 2 generations on · 4 of its ownK191816 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2020
- Descendant · 3 generations on · 3 of its ownK201471 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2021
- Descendant · 2 generations on · 1 of its ownK212327 M-Vizion MonoblocMedacta International S.A. · 2022
- Descendant · cites it directly · 1 of its ownK191781 Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis SystemZimmer GmbH · 2019
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K170690M-Vizion Femoral Revision SystemMedacta International S.A. · 2017 · cites it directly5descendants
- K191816M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2020 · 2 generations on4descendants
- K201471M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2021 · 3 generations on3descendants
- K212327M-Vizion MonoblocMedacta International S.A. · 2022 · 2 generations on1descendant
- K191781Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis SystemZimmer GmbH · 2019 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −6 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| −5 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| −4 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| −3 | K022549 | Restoration Modular System | Howmedica Osteonics Corp. | 2002 | 3 |
| −2 | K032380 | Wagner Cone Prosthesis | Centerpulse Orthopedics, Inc. | 2003 | — |
| −1 | K113556 | Wagner Cone Prosthesis System | Zimmer GmbH | 2012 | 1 |
| 0 (this device) | K161192 | Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System | Zimmer GmbH | 2016 | — |
| +1 | K170690 | M-Vizion Femoral Revision System | Medacta International S.A. | 2017 | — |
| +2 | K191816 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2020 | — |
| +3 | K201471 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2021 | — |
| +2 | K212327 | M-Vizion Monobloc | Medacta International S.A. | 2022 | — |
| +1 | K191781 | Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System | Zimmer GmbH | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | K043356 | Wagner SL Revision Stem LateralSummary page 5…mer semi constrained cemented prosthesis Predicate Device: Wagner SL Revision Stem Lateral, manufactured by Zimmer GmbH, K043356, cleared April 18, 2005 Wagner Cone Prosthesis® System, manufactured by Zimmer GmbH,… | 2005 |
| * | K113556 | Wagner Cone Prosthesis SystemSummary page 5…Zimmer GmbH, K043356, cleared April 18, 2005 Wagner Cone Prosthesis® System, manufactured by Zimmer GmbH, K113556, cleared February 17, 2012 Device Description: The Wagner SL Revision Stem Lateral is a straight stem ma… | 2012 |
What descends from it? (8)
2 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?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 12 of the 22 ancestors have a recall of any class.
- Of its descendants, K170690 (Medacta International S.A., 2017) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K043356.
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. 2016, this device’s year, is highlighted.
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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161192: Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161192
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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