510(k) · Cleared
ClearedSL-Plus Mia Femoral Stems 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 Aug 28, 2012 as substantially equivalent to K082371 (Smith & Nephew, Inc., 2009) and 1 other predicate after a 28-day review. Its family tree reaches back 5 generations to 1994. 8 later devices descend from it.
- Decided
- Aug 28, 2012
- Review
- 28 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K932481 (1994). 6 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK932481 SL-Plus and SLR-PlusEncore Orthopedics, Inc. · 1994
- 4 generations backK001942 SL-Plus and SLR-Plus StemsPlus Orthopedics · 2000
- 3 generations backK021178 SL-Plus Lateralized StemPlus Orthopedics · 2002
- 2 generations backK072852 SL-Plus Standard and Lateral Hip StemsSmith & Nephew, Inc. · 2008
- 1 generation backK120211 SL-Plus Standard and Lateral Femoral Stem with TI/HA CoatingSmith & Nephew, Inc. · 2012
- This deviceK122296 SL-Plus Mia Femoral Stems with TI/HA CoatingSmith & Nephew, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · Recalled
- Descendant · cites it directly · 3 of its ownK143096 SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HASmith & Nephew, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK223103 BethaLoc® stem cementless HAImplantcast GmbH · 2023
- Descendant · 2 generations on · 0 of its ownK260037 implantcast Packaging System UpdateImplantcast GmbH · 2026
- Descendant · 2 generations on · 0 of its ownK240783 Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular…Smith & Nephew, Inc. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · cites it directly3descendants
- K143096SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HASmith & Nephew, Inc. · 2015 · cites it directly3descendants
- K223103BethaLoc® stem cementless HAImplantcast GmbH · 2023 · cites it directly1descendant
- K260037implantcast Packaging System UpdateImplantcast GmbH · 2026 · 2 generations on0descendants
- K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K932481 | SL-Plus and SLR-Plus | Encore Orthopedics, Inc. | 1994 | — |
| −4 | K001942 | SL-Plus and SLR-Plus Stems | Plus Orthopedics | 2000 | — |
| −3 | K021178 | SL-Plus Lateralized Stem | Plus Orthopedics | 2002 | — |
| −2 | K072852 | SL-Plus Standard and Lateral Hip Stems | Smith & Nephew, Inc. | 2008 | — |
| −1 | K120211 | SL-Plus Standard and Lateral Femoral Stem with TI/HA Coating | Smith & Nephew, Inc. | 2012 | — |
| 0 (this device) | K122296 | SL-Plus Mia Femoral Stems with TI/HA Coating | Smith & Nephew, Inc. | 2012 | — |
| +1 | K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | 2022 | 1 |
| +1 | K143096 | SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA | Smith & Nephew, Inc. | 2015 | — |
| +1 | K223103 | BethaLoc® stem cementless HA | Implantcast GmbH | 2023 | — |
| +2 | K260037 | implantcast Packaging System Update | Implantcast GmbH | 2026 | — |
| +2 | K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners… | Smith & Nephew, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 |
|---|---|---|---|
| * | K082371 | Smith & Nephew SL-Plus Mia Standard and Lateral Femoral Hip StemSummary page 1…LZO, KWY, LWJ Device Description The SL-PLUS0 MIA FemoraL Stem with Ti/HA is based on the uncoated design of SL-PLUS' MIA Femoral Stem cleared via K(082371. The subject stems are made from forged titanium alloy Ti- 6A1-4Nb with adouble coating (triple layer): titanium plasma sprayed c… | 2009 |
| * | K120211 | SL-Plus Standard and Lateral Femoral Stem with TI/HA CoatingSummary page 1…r of hydroxyapatite. The Ti/HA coating is identical to the Ti/HA coating on the SL-PLUS0 Standard and Lateral Femoral Stems with Ti/HA cleared via premarket notification K120211. Intended Use The SL PLUS0 MIA Stem with and without Ti/HA isindicated for individuals undergoing primary and revision surgery w… | 2012 |
What descends from it? (8)
3 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 18 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K211176 (Smith & Nephew, Inc., 2022) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K082371.
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 PLUS* MIA Stem with and without Ti/HA is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip…
Read the full statement (169 words)
The SL PLUS* MIA Stem with and without Ti/HA is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease indluding rheumatoid arthritis, arthritis secondary to avariety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
The SL PLUS0 MIA Stem with and without Ti/HA isfor single use only and isintended to be implanted without bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122296 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122296: SL-Plus Mia Femoral Stems 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/K122296
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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