510(k) · Cleared
ClearedSL-Plus Standard and Lateral Femoral Stem with TI/HA Coating
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 Jul 19, 2012 as substantially equivalent to K072852 (Smith & Nephew, Inc., 2008) after a 177-day review. Its family tree reaches back 4 generations to 1994. 18 later devices descend from it.
- Decided
- Jul 19, 2012
- Review
- 177 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K932481 (1994). 18 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK932481 SL-Plus and SLR-PlusEncore Orthopedics, Inc. · 1994
- 3 generations backK001942 SL-Plus and SLR-Plus StemsPlus Orthopedics · 2000
- 2 generations backK021178 SL-Plus Lateralized StemPlus Orthopedics · 2002
- 1 generation backK072852 SL-Plus Standard and Lateral Hip StemsSmith & Nephew, Inc. · 2008
- This deviceK120211 SL-Plus Standard and Lateral Femoral Stem with TI/HA CoatingSmith & Nephew, Inc. · 2012
- Descendant · cites it directly · 11 of its ownK130728 Polarstem Standard and Lateral Femoral Stems with TI/HASmith & Nephew, Inc. · 2013 · Recalled
- Descendant · cites it directly · 8 of its ownK122296 SL-Plus Mia Femoral Stems with TI/HA CoatingSmith & Nephew, Inc. · 2012
- Descendant · 2 generations on · 7 of its ownK143739 POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem…Smith & Nephew, Inc. · 2015 · Recalled
- Descendant · cites it directly · 5 of its ownK122244 Polarcup Dual Mobility SystemSmith & Nephew, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K130728Polarstem Standard and Lateral Femoral Stems with TI/HASmith & Nephew, Inc. · 2013 · cites it directly11descendants
- K122296SL-Plus Mia Femoral Stems with TI/HA CoatingSmith & Nephew, Inc. · 2012 · cites it directly8descendants
- K143739POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HASmith & Nephew, Inc. · 2015 · 2 generations on7descendants
- K122244Polarcup Dual Mobility SystemSmith & Nephew, Inc. · 2012 · cites it directly5descendants
- K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932481 | SL-Plus and SLR-Plus | Encore Orthopedics, Inc. | 1994 | — |
| −3 | K001942 | SL-Plus and SLR-Plus Stems | Plus Orthopedics | 2000 | — |
| −2 | K021178 | SL-Plus Lateralized Stem | Plus Orthopedics | 2002 | — |
| −1 | K072852 | SL-Plus Standard and Lateral Hip Stems | Smith & Nephew, Inc. | 2008 | — |
| 0 (this device) | K120211 | SL-Plus Standard and Lateral Femoral Stem with TI/HA Coating | Smith & Nephew, Inc. | 2012 | — |
| +1 | K130728 | Polarstem Standard and Lateral Femoral Stems with TI/HA | Smith & Nephew, Inc. | 2013 | 1 |
| +1 | K122296 | SL-Plus Mia Femoral Stems with TI/HA Coating | Smith & Nephew, Inc. | 2012 | — |
| +2 | K143739 | POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA | Smith & Nephew, Inc. | 2015 | 1 |
| +1 | K122244 | Polarcup Dual Mobility System | Smith & Nephew, Inc. | 2012 | — |
| +1 | K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | 2022 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072852 | SL-Plus Standard and Lateral Hip StemsSummary page 1…, LWJ Device Description The SL-PLUS0 Standard and Lateral Stems with Ti/HA are based on the uncoated design of SL- PLUS* Standard and Lateral Femoral Stems cleared via K072852. The subject stems are made from forged titanium alloy Ti-6A1-4Nb with a double coating (triple layer): titanium plasma sprayed c… | 2008 |
| Kept off the family tree | K111584 | FDA’s K111584 is Xylos Macro-Porous Surgical Mesh Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2011 |
What descends from it? (18)
See all 186 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130728 | Polarstem Standard and Lateral Femoral Stems with TI/HA | 2013 | 11 |
| K122296 | SL-Plus Mia Femoral Stems with TI/HA Coating | 2012 | 8 |
| K122244 | Polarcup Dual Mobility System | 2012 | 5 |
| K211176 | Smith & Nephew Hip Systems | 2022 | 3 |
| K143096 | SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA | 2015 | 3 |
| K170473 | C2 femoral stem | 2017 | 0 |
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 18 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K130728 (Smith & Nephew, Inc., 2013) has gone furthest, with 11 descendants of its own.
- 5 other devices also cite its predicate K072852.
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?
The SL-PLUS0 Standard Femoral Stem with Ti/HA is intended for advanced hip joint wear due to degenerative, post-traumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head.
The SL-PLUS0 Lateratized Stem with Ti/HA is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute).
These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion-
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120211 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120211: SL-Plus Standard and Lateral Femoral Stem with TI/HA Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120211
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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