510(k) · Cleared
ClearedSL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA
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 Mar 24, 2015 as substantially equivalent to K122296 (Smith & Nephew, Inc., 2012) and 1 other predicate after a 147-day review. Its family tree reaches back 6 generations to 1994. 3 later devices descend from it.
- Decided
- Mar 24, 2015
- Review
- 147 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K932481 (1994). 7 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK932481 SL-Plus and SLR-PlusEncore Orthopedics, Inc. · 1994
- 5 generations backK001942 SL-Plus and SLR-Plus StemsPlus Orthopedics · 2000
- 4 generations backK021178 SL-Plus Lateralized StemPlus Orthopedics · 2002
- 3 generations backK072852 SL-Plus Standard and Lateral Hip StemsSmith & Nephew, Inc. · 2008
- 2 generations backK120211 SL-Plus Standard and Lateral Femoral Stem with TI/HA CoatingSmith & Nephew, Inc. · 2012
- 1 generation backK122296 SL-Plus Mia Femoral Stems with TI/HA CoatingSmith & Nephew, Inc. · 2012
- This deviceK143096 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 · cites it directly · 0 of its ownK170473 C2 femoral stemLima Corporate S.P.A. · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K932481 | SL-Plus and SLR-Plus | Encore Orthopedics, Inc. | 1994 | — |
| −5 | K001942 | SL-Plus and SLR-Plus Stems | Plus Orthopedics | 2000 | — |
| −4 | K021178 | SL-Plus Lateralized Stem | Plus Orthopedics | 2002 | — |
| −3 | K072852 | SL-Plus Standard and Lateral Hip Stems | Smith & Nephew, Inc. | 2008 | — |
| −2 | K120211 | SL-Plus Standard and Lateral Femoral Stem with TI/HA Coating | Smith & Nephew, Inc. | 2012 | — |
| −1 | K122296 | SL-Plus Mia Femoral Stems with TI/HA Coating | Smith & Nephew, Inc. | 2012 | — |
| 0 (this device) | 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 | — |
| +1 | K170473 | C2 femoral stem | Lima Corporate S.P.A. | 2017 | — |
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 |
|---|---|---|
| 2017 | 1 | 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? (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 |
|---|---|---|---|
| * | K122296 | SL-Plus Mia Femoral Stems with TI/HA CoatingSummary page 5…Y, LWJ Device Description The SL-PLUS™ MIA Femoral Stem with Ti/HA coated by Medicoat AG is identical to the coated design of the SL-PLUS™ MIA Femoral Stem cleared via K122296. The subject stems are made from forged titanium alloy, Ti-6Al-7Nb, with a double coating (triple layer): titanium plasma sprayed… | 2012 |
| * | K120211 | SL-Plus Standard and Lateral Femoral Stem with TI/HA CoatingSummary page 5…ia premarket notification K122296. The SL-PLUS™ Femoral Stem with Ti/HA coated by Medicoat AG is identical to the coated design of the SL-PLUS™ Femoral Stem cleared via K120211. The subject stems are made from forged titanium alloy, Ti-6Al-7Nb, with a double coating (triple layer): titanium plasma sprayed… | 2012 |
What descends from it? (3)
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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K223103 (Implantcast GmbH, 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K122296.
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. 2015, 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 and the SL-PLUS™ MIA Stem with Ti/HA (INTEGRATION-PLUS™) is indicated for: Indications Standard Stem The SL-PLUS MIA Hip Stem 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…
Read the full statement (386 words)
The SL-PLUS™ MIA Stem and the SL-PLUS™ MIA Stem with Ti/HA (INTEGRATION-PLUS™) is indicated for:
Indications Standard Stem
The SL-PLUS MIA Hip Stem 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.
Indications Lateral Stem
The SL-PLUS MIA Laterialzed stem is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute)
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety 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.
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.
The SL-PLUS™ Stem and the SL-PLUS™ Stem with Ti/HA (INTEGRATION-PLUS™) is indicated for:
Indications Standard Stem
The SL-PLUS Stem is intended for advanced hip joint wear due to degenerative, post-traumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head
Indications Lateral Stem
The SL-PLUS Laterialzed stem is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute)
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety 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.
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/K143096 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143096: SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143096
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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