510(k) · Cleared
ClearedSmith & Nephew SL-Plus Mia Standard and Lateral Femoral Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Feb 9, 2009 after a 175-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Feb 9, 2009
- Review
- 175 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK082371 Smith & Nephew SL-Plus Mia Standard and Lateral Femoral Hip StemSmith & Nephew, Inc. · 2009
- Descendant · cites it directly · 8 of its ownK122296 SL-Plus Mia Femoral Stems with TI/HA CoatingSmith & Nephew, Inc. · 2012
- Descendant · 2 generations on · 3 of its ownK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · Recalled
- Descendant · 2 generations on · 3 of its ownK143096 SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HASmith & Nephew, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK223103 BethaLoc® stem cementless HAImplantcast GmbH · 2023
- Descendant · 3 generations on · 0 of its ownK260037 implantcast Packaging System UpdateImplantcast GmbH · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K122296SL-Plus Mia Femoral Stems with TI/HA CoatingSmith & Nephew, Inc. · 2012 · cites it directly8descendants
- K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · 2 generations on3descendants
- K143096SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HASmith & Nephew, Inc. · 2015 · 2 generations on3descendants
- K223103BethaLoc® stem cementless HAImplantcast GmbH · 2023 · 2 generations on1descendant
- K260037implantcast Packaging System UpdateImplantcast GmbH · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082371 | Smith & Nephew SL-Plus Mia Standard and Lateral Femoral Hip Stem | Smith & Nephew, Inc. | 2009 | — |
| +1 | K122296 | SL-Plus Mia Femoral Stems with TI/HA Coating | Smith & Nephew, Inc. | 2012 | — |
| +2 | K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | 2022 | 1 |
| +2 | K143096 | SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA | Smith & Nephew, Inc. | 2015 | — |
| +2 | K223103 | BethaLoc® stem cementless HA | Implantcast GmbH | 2023 | — |
| +3 | K260037 | implantcast Packaging System Update | Implantcast GmbH | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
2 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, K122296 (Smith & Nephew, Inc., 2012) has gone furthest, with 8 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. 2009, 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 | — |
https://510kreport.com/device/K082371 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082371: Smith & Nephew SL-Plus Mia Standard and Lateral Femoral Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082371
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026