510(k) · Cleared
ClearedSL-Plus and SLR-Plus Stems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plus Orthopedics · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on Jul 25, 2000 as substantially equivalent to K932481 (Encore Orthopedics, Inc., 1994) after a 29-day review. Its family tree reaches back 1 generation to 1994. 129 later devices descend from it.
- Decided
- Jul 25, 2000
- Review
- 29 days
- Class
- Class II
- Product code
- LWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K932481 (1994). 129 later devices descend from it, 9 citing it directly.
- Root · 1 generation backK932481 SL-Plus and SLR-PlusEncore Orthopedics, Inc. · 1994
- This deviceK001942 SL-Plus and SLR-Plus StemsPlus Orthopedics · 2000
- Descendant · cites it directly · 126 of its ownK021178 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
Showing 5 of 129 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 129 · See all- K021178SL-Plus Lateralized StemPlus Orthopedics · 2002 · cites it directly126descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932481 | SL-Plus and SLR-Plus | Encore Orthopedics, Inc. | 1994 | — |
| 0 (this device) | K001942 | SL-Plus and SLR-Plus Stems | Plus Orthopedics | 2000 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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 LWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K932481 | SL-Plus and SLR-PlusSummary page 1…n Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented name: 21 CFR 888.3350 (87 LWJ) Equivalence: SL-PLUSO and SLR-PLUS° Stems, K932481, SIE 06/08/94 Characteristics: The SL-PLUSO and SLR-PLUS® Femoral Stems are of a double taper d… | 1994 |
What descends from it? (129)
See all 1299 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021178 | SL-Plus Lateralized Stem | 2002 | 126 |
| K041950 | Apex K2 Hip System | 2004 | 62 |
| K072857 | Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + Apricot | 2008 | 39 |
| K072852 | SL-Plus Standard and Lateral Hip Stems | 2008 | 27 |
| K060072 | Monoblock Press-Fit Hip Stem | 2006 | 7 |
| K093991 | SLR-Plus Standard and Lateral Femoral Stems | 2010 | 5 |
| K052275 | Smith & Nephew Platform Hip Stem | 2005 | 1 |
| K024134 | Uni Hip Stem | 2003 | 1 |
| K123598 | Smith & Nephew, Inc. Hip System Instrumentation | 2013 | 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?
- Its one ancestor has no recall.
- Of its descendants, K021178 (Plus Orthopedics, 2002) has gone furthest, with 126 descendants of its own.
How does its category compare?
All LWJ devicesLWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LWJ
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · LWJ
Too few LWJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LWJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LWJ
51in 2025
MAUDE reports naming product code LWJ, 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 | 2 | — | 10 | 68 |
| 2008 | 1 | — | 2 | 72 |
| 2009 | 1 | — | 2 | 84 |
| 2010 | 0 | — | 0 | 132 |
| 2011 | 1 | — | 0 | 255 |
| 2012 | 1 | — | 0 | 390 |
| 2013 | 0 | — | 1 | 522 |
| 2014 | 0 | — | 0 | 452 |
| 2015 | 0 | — | 0 | 310 |
| 2016 | 0 | — | 0 | 293 |
| 2017 | 0 | — | 0 | 311 |
| 2018 | 0 | — | 0 | 227 |
| 2019 | 0 | — | 0 | 210 |
| 2020 | 0 | — | 0 | 189 |
| 2021 | 0 | — | 0 | 155 |
| 2022 | 0 | — | 0 | 91 |
| 2023 | 0 | — | 2 | 72 |
| 2024 | 0 | — | 0 | 54 |
| 2025 | 0 | — | 0 | 51 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SL-PLUS® Stem primary component 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. The SLR-PLUS" Stem, a revision component, is also available to replace previously failed femoral hip arthroplasties. Both components can be used with or without cement. 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/K001942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001942: SL-Plus and SLR-Plus Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001942
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026