510(k) · Cleared
ClearedWagner Revision Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intermedics Orthopedics · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Aug 5, 1996 after a 175-day review. The FDA summary names its predicate without a number. 104 later devices descend from it.
- Decided
- Aug 5, 1996
- Review
- 175 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 0
104 later devices descend from it, 3 citing it directly.
- This deviceK960588 Wagner Revision StemIntermedics Orthopedics · 1996
- Descendant · cites it directly · 102 of its ownK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- Descendant · 2 generations on · 101 of its ownK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- Descendant · 3 generations on · 54 of its ownK022549 Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · Recalled
- Descendant · 3 generations on · 53 of its ownK103479 Novel Tapered Hip StemStryker Corp. · 2011
- Descendant · 3 generations on · 46 of its ownK120578 Accolade II Hip StemHowmedica Osteonics · 2012 · Recalled
Showing 5 of 104 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 104 · See all- K983404Type 3 Femoral ComponentsHowmedica Corp. · 1998 · cites it directly102descendants
- K0131062 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · 2 generations on101descendants
- K022549Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · 3 generations on54descendants
- K103479Novel Tapered Hip StemStryker Corp. · 2011 · 3 generations on53descendants
- K120578Accolade II Hip StemHowmedica Osteonics · 2012 · 3 generations on46descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960588 | Wagner Revision Stem | Intermedics Orthopedics | 1996 | — |
| +1 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| +2 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| +3 | K022549 | Restoration Modular System | Howmedica Osteonics Corp. | 2002 | 3 |
| +3 | K103479 | Novel Tapered Hip Stem | Stryker Corp. | 2011 | — |
| +3 | K120578 | Accolade II Hip Stem | Howmedica Osteonics | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 7 | 0 |
| 2016 | 8 | 0 |
| 2017 | 9 | 0 |
| 2018 | 3 | 0 |
| 2019 | 9 | 0 |
| 2020 | 7 | 0 |
| 2021 | 6 | 0 |
| 2022 | 9 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 12 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | — | Miiller Type Proximal Femur Named without a submission number | |
| * | — | Proximal Third Femoral Prosthesis Named without a submission number |
What descends from it? (104)
See all 1043 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?
- Of its descendants, K983404 (Howmedica Corp., 1998) has gone furthest, with 102 descendants of its own.
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?
This device is intended for cementless application where primary fixation occurs predominantly in the distal region and is primarily used in clinical situations where there are deficiencies in the proximal femur due to extensive bone resorption and/or damage in the prosthetic bed.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960588 · printed Nov 5, 2026
Cite this page
510(k) Report. “K960588: Wagner Revision Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960588
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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