510(k) · Cleared
Recalled · Class II · 2012Wagner 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 Feb 17, 2012 as substantially equivalent to K032380 (Centerpulse Orthopedics, Inc., 2003) and 1 other predicate after a 78-day review. Its family tree reaches back 6 generations to 1994. 9 later devices descend from it. It has been recalled once.
- Decided
- Feb 17, 2012
- Review
- 78 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K921308 (1994). 19 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 5 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
- 4 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- 3 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- 2 generations backK022549 Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · Recalled
- 1 generation backK032380 Wagner Cone ProsthesisCenterpulse Orthopedics, Inc. · 2003
- This deviceK113556 Wagner Cone Prosthesis SystemZimmer GmbH · 2012
- 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 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · 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 |
|---|---|---|---|---|---|
| −6 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −5 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| −4 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| −3 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| −2 | K022549 | Restoration Modular System | Howmedica Osteonics Corp. | 2002 | 3 |
| −1 | K032380 | Wagner Cone Prosthesis | Centerpulse Orthopedics, Inc. | 2003 | — |
| 0 (this device) | K113556 | Wagner Cone Prosthesis System | Zimmer GmbH | 2012 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K032380 | Wagner Cone ProsthesisSummary page 2…(g5~2ofC2) Predicate Device: Wagner Cone Prosthesis, manufactured by Centerpulse Orthopaedics Inc., K032380, cleared September 22, 2003 CLS~M SpotornoTM F… | 2003 |
| * | K042249 | CLS Spotorno StemSummary page 2…September 22, 2003 CLS~M SpotornoTM Femoral Stem, manufactured by Zimmer GmbH., K042249, cleared September 15, 2004 Device Description: The Wagner Cone Pr… | 2004 |
What descends from it? (9)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 4, 2012 | Class II | Z-0221-2013 | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 11 of the 19 ancestors have a recall of any class.
- Of its descendants, K161192 (Zimmer GmbH, 2016) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K032380.
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. 2012, 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/K113556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113556: 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/K113556
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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