510(k) · Cleared
Recalled · Class II · 2012CLS Spotorno Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Austin, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Sep 15, 2004 after a 27-day review. The FDA summary names its predicate without a number. 24 later devices descend from it. It has been recalled once.
- Decided
- Sep 15, 2004
- Review
- 27 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 1
- Predicates
- 0
24 later devices descend from it, 4 citing it directly.
- This deviceK042249 CLS Spotorno StemZimmer Austin, Inc. · 2004
- Descendant · cites it directly · 11 of its ownK103431 Coren Total Hip SystemCorentec Co., Ltd. · 2011
- 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 · 2 generations on · 8 of its ownK121665 Bencox Foret & Bencox DeltaCorentec Co., Ltd. · 2012
- Descendant · 2 generations on · 8 of its ownK120924 Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes)…Corentec Co., Ltd. · 2012
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K103431Coren Total Hip SystemCorentec Co., Ltd. · 2011 · cites it directly11descendants
- K113556Wagner Cone Prosthesis SystemZimmer GmbH · 2012 · cites it directly9descendants
- K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH · 2016 · 2 generations on8descendants
- K121665Bencox Foret & Bencox DeltaCorentec Co., Ltd. · 2012 · 2 generations on8descendants
- K120924Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo Cup Screw…Corentec Co., Ltd. · 2012 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042249 | CLS Spotorno Stem | Zimmer Austin, Inc. | 2004 | — |
| +1 | K103431 | Coren Total Hip System | Corentec Co., Ltd. | 2011 | — |
| +1 | K113556 | Wagner Cone Prosthesis System | Zimmer GmbH | 2012 | 1 |
| +2 | K161192 | Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System | Zimmer GmbH | 2016 | — |
| +2 | K121665 | Bencox Foret & Bencox Delta | Corentec Co., Ltd. | 2012 | — |
| +2 | K120924 | Bencox Mirabo Cup Bencox Mirabo Insert (Standard& Elevated Tyes) Bencox Mirabo… | Corentec Co., Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | — | CLS Stems Named without a submission number |
What descends from it? (24)
See all 244 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-0234-2013 | 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?
- Of its descendants, K103431 (Corentec Co., Ltd., 2011) has gone furthest, with 11 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?
The CLSTM Spotorno TM Femoral Stem is intended for cementless use in total hip replacement in treatment of the following:
* patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis and conditions of inflammatory degenerative 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/K042249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042249: CLS Spotorno Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042249
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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