510(k) · Cleared
ClearedWagner Cone Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centerpulse Orthopedics, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Sep 22, 2003 as substantially equivalent to K955296 (Link America, Inc., 1996) and 3 other predicates after a 52-day review. Its family tree reaches back 5 generations to 1994. 24 later devices descend from it.
- Decided
- Sep 22, 2003
- Review
- 52 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K921308 (1994). 17 ancestors in all. 24 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 4 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
- 3 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- 2 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- 1 generation backK022549 Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · Recalled
- This deviceK032380 Wagner Cone ProsthesisCenterpulse Orthopedics, Inc. · 2003
- Descendant · cites it directly · 13 of its ownK112158 Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups…Lima Corporate S.P.A. · 2012
- Descendant · cites it directly · 9 of its ownK113556 Wagner Cone Prosthesis SystemZimmer GmbH · 2012 · Recalled
- Descendant · 2 generations on · 8 of its ownK161192 Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH · 2016
- Descendant · 3 generations on · 5 of its ownK170690 M-Vizion Femoral Revision SystemMedacta International S.A. · 2017
- Descendant · 2 generations on · 5 of its ownK141327 Minima S SystemLima Corporate S.P.A. · 2014
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A. · 2012 · cites it directly13descendants
- K113556Wagner Cone Prosthesis SystemZimmer GmbH · 2012 · cites it directly9descendants
- K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH · 2016 · 2 generations on8descendants
- K170690M-Vizion Femoral Revision SystemMedacta International S.A. · 2017 · 3 generations on5descendants
- K141327Minima S SystemLima Corporate S.P.A. · 2014 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −4 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| −3 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| −2 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| −1 | K022549 | Restoration Modular System | Howmedica Osteonics Corp. | 2002 | 3 |
| 0 (this device) | K032380 | Wagner Cone Prosthesis | Centerpulse Orthopedics, Inc. | 2003 | — |
| +1 | K112158 | Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock… | Lima Corporate S.P.A. | 2012 | — |
| +1 | K113556 | Wagner Cone Prosthesis System | Zimmer GmbH | 2012 | 1 |
| +2 | K161192 | Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System | Zimmer GmbH | 2016 | — |
| +3 | K170690 | M-Vizion Femoral Revision System | Medacta International S.A. | 2017 | — |
| +2 | K141327 | Minima S System | Lima Corporate S.P.A. | 2014 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K955296 | Link MP Reconstruction HipSummary page 1…I1 per 21 CFR 3888.3353, reviewed by the Orthopedic Devices panel. PREDICATE DEVICES: 0 MPTMReconstruction Hip Stem by Waldemar Link GmbH & Co KG. (K955296) 0 RestorationTMModular System by Howinedica Osteoiiics Corp. (K022549) 0 Wagner Revision Stem (K960588) 0 Precede… | 1996 |
| * | K022549 | Restoration Modular SystemSummary page 1…panel. PREDICATE DEVICES: 0 MPTMReconstruction Hip Stem by Waldemar Link GmbH & Co KG. (K955296) 0 RestorationTMModular System by Howinedica Osteoiiics Corp. (K022549) 0 Wagner Revision Stem (K960588) 0 Precedent Revision Hip Stem (K972637) DEVICE DESCRIPTIOY: This stein is a titanium… | 2002 |
| * | K960588 | Wagner Revision StemSummary page 1…Reconstruction Hip Stem by Waldemar Link GmbH & Co KG. (K955296) 0 RestorationTMModular System by Howinedica Osteoiiics Corp. (K022549) 0 Wagner Revision Stem (K960588) 0 Precedent Revision Hip Stem (K972637) DEVICE DESCRIPTIOY: This stein is a titanium-aluminum-niobium alloy conical config… | 1996 |
| * | K972637 | Precedent Revision Hip SystemSummary page 1…& Co KG. (K955296) 0 RestorationTMModular System by Howinedica Osteoiiics Corp. (K022549) 0 Wagner Revision Stem (K960588) 0 Precedent Revision Hip Stem (K972637) DEVICE DESCRIPTIOY: This stein is a titanium-aluminum-niobium alloy conical configuration with a taper. The design features a c… | 1997 |
What descends from it? (24)
See all 242 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 9 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 10 of the 17 ancestors have a recall of any class.
- Of its descendants, K112158 (Lima Corporate S.P.A., 2012) has gone furthest, with 13 descendants of its own.
- 6 other devices also cite its predicate K955296.
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 Cone Prosthesis is intended for prosthetic replacement of the proximal portion of the femur in total hip arthroplasty. This device is intended for cementless application where primary fixation occurs predominantly in the distal region. Specific diagnostic indications for use of the Wagner Cone Prosthesis are:
patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis;
those 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/K032380 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032380: Wagner Cone Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032380
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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