510(k) · Cleared
ClearedWagner SL Revision Stem Lateral and 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 Aug 6, 2019 as substantially equivalent to K043356 (Zimmer Austin, Inc., 2005) and 2 other predicates after a 35-day review. Its family tree reaches back 8 generations to 1994. 1 later device descends from it.
- Decided
- Aug 6, 2019
- Review
- 35 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K921308 (1994). 23 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 7 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
- 6 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- 5 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- 4 generations backK022549 Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · Recalled
- 3 generations backK032380 Wagner Cone ProsthesisCenterpulse Orthopedics, Inc. · 2003
- 2 generations backK113556 Wagner Cone Prosthesis SystemZimmer GmbH · 2012 · Recalled
- 1 generation backK161192 Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH · 2016
- This deviceK191781 Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis SystemZimmer GmbH · 2019
- Descendant · cites it directly · 0 of its ownK200112 Zimmer Hip Joint ReplacementZimmer GmbH · 2020 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K200112Zimmer Hip Joint ReplacementZimmer GmbH · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −7 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| −6 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| −5 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| −4 | K022549 | Restoration Modular System | Howmedica Osteonics Corp. | 2002 | 3 |
| −3 | K032380 | Wagner Cone Prosthesis | Centerpulse Orthopedics, Inc. | 2003 | — |
| −2 | K113556 | Wagner Cone Prosthesis System | Zimmer GmbH | 2012 | 1 |
| −1 | K161192 | Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System | Zimmer GmbH | 2016 | — |
| 0 (this device) | K191781 | Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System | Zimmer GmbH | 2019 | — |
| +1 | K200112 | Zimmer Hip Joint Replacement | Zimmer GmbH | 2020 | 2 |
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 |
|---|---|---|
| 2020 | 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? (3)
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…cemented prosthesis Predicate Device: Wagner SL Revision Stem Lateral, manufactured by Zimmer GmbH, K043356, cleared 04/18/2005 Wagner SL Revision Stem Lateral, manufactured by Zimmer… | 2005 |
| * | K161192 | Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemSummary page 5…GmbH, K043356, cleared 04/18/2005 Wagner SL Revision Stem Lateral, manufactured by Zimmer GmbH, K161192, cleared 07/08/2016 Wagner Cone Prosthesis System, manufactured by Zimmer… | 2016 |
| * | K113556 | Wagner Cone Prosthesis SystemSummary page 5…GmbH, K161192, cleared 07/08/2016 Wagner Cone Prosthesis System, manufactured by Zimmer GmbH, K113556, cleared 02/17/2012 K191781 Effective date:… | 2012 |
| † | K182048 | Avenir Complete Hip System | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200112 | Zimmer Hip Joint Replacement | 2020 | 0 |
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 25 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 12 of the 23 ancestors have a recall of any class.
- Of its descendants, K200112 (Zimmer GmbH, 2020) has gone furthest, with 0 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. 2019, 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.
• 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191781: Wagner SL Revision Stem Lateral and 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/K191781
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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