510(k) · Cleared
ClearedSL-Plus Lateralized Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plus Orthopedics · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on May 14, 2002 as substantially equivalent to K001942 (Plus Orthopedics, 2000) after a 29-day review. Its family tree reaches back 2 generations to 1994. 126 later devices descend from it.
- Decided
- May 14, 2002
- Review
- 29 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K932481 (1994). 126 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK932481 SL-Plus and SLR-PlusEncore Orthopedics, Inc. · 1994
- 1 generation backK001942 SL-Plus and SLR-Plus StemsPlus Orthopedics · 2000
- This deviceK021178 SL-Plus Lateralized StemPlus Orthopedics · 2002
- Descendant · cites it directly · 62 of its ownK041950 Apex K2 Hip SystemApex Surgical, LLC · 2004 · Recalled
- Descendant · 2 generations on · 58 of its ownK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 53 of its ownK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- Descendant · 3 generations on · 52 of its ownK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- Descendant · 4 generations on · 48 of its ownK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
Showing 5 of 126 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 126 · See all- K041950Apex K2 Hip SystemApex Surgical, LLC · 2004 · cites it directly62descendants
- K090845Apex Arc Hip StemOmni Life Science, Inc. · 2010 · 2 generations on58descendants
- K111193Apex Arc Hip StemOmni Life Science, Inc. · 2011 · 3 generations on53descendants
- K113242Apex Arc Hip StemOmni Life Science, Inc. · 2012 · 3 generations on52descendants
- K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · 4 generations on48descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932481 | SL-Plus and SLR-Plus | Encore Orthopedics, Inc. | 1994 | — |
| −1 | K001942 | SL-Plus and SLR-Plus Stems | Plus Orthopedics | 2000 | — |
| 0 (this device) | K021178 | SL-Plus Lateralized Stem | Plus Orthopedics | 2002 | — |
| +1 | K041950 | Apex K2 Hip System | Apex Surgical, LLC | 2004 | 1 |
| +2 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| +3 | K111193 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2011 | — |
| +3 | K113242 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2012 | — |
| +4 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 6 | 0 |
| 2012 | 8 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 9 | 0 |
| 2021 | 10 | 0 |
| 2022 | 8 | 0 |
| 2023 | 9 | 0 |
| 2024 | 9 | 0 |
| 2025 | 16 | 0 |
| 2026 | 9 | 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 JDI? 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 JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 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 |
|---|---|---|---|
| * | K001942 | SL-Plus and SLR-Plus StemsSummary page 1…Hip Joint, Femoral Component, Cementless Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented 21 CFR 888.3350 (87 LWJ and 87 JDI) SL-PLUS® and SLR-PLUS® Stems, K001942, S/E 7/25/00 We added 12 sizes, sizes 1 through 12, of lateralized stems to the SL- PLUS® Stems, which were cleared for marketin… | 2000 |
What descends from it? (126)
See all 1265 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 8 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K041950 (Apex Surgical, LLC, 2004) has gone furthest, with 62 descendants of its own.
- 8 other devices also cite its predicate K001942.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, 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 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The SL-PLUS® Lateralized Stem is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head and neck has been subject to disease or trauma. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021178 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021178: SL-Plus Lateralized Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021178
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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