510(k) · Cleared
ClearedModular-Plus Revision Stem
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 May 4, 2000 as substantially equivalent to K955296 (Link America, Inc., 1996) after a 149-day review. Its family tree reaches back 1 generation to 1996. 32 later devices descend from it.
- Decided
- May 4, 2000
- Review
- 149 days
- Class
- Class II
- Product code
- LWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955296 (1996). 32 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK955296 Link MP Reconstruction HipLink America, Inc. · 1996 · Recalled
- This deviceK994126 Modular-Plus Revision StemPlus Orthopedics · 2000
- Descendant · cites it directly · 30 of its ownK030971 Modification to Modular Plus Revision StemPlus Orthopedics · 2003
- Descendant · 2 generations on · 29 of its ownK032709 Modular Plus Hip StemPlus Orthopedics · 2003
- Descendant · cites it directly · 27 of its ownK092331 Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200…Encore Medical L.P. · 2010 · Recalled
- Descendant · 2 generations on · 13 of its ownK112158 Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups…Lima Corporate S.P.A. · 2012
- Descendant · 2 generations on · 7 of its ownK151739 Revision Femoral StemLima Corporate S.P.A. · 2015
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K030971Modification to Modular Plus Revision StemPlus Orthopedics · 2003 · cites it directly30descendants
- K032709Modular Plus Hip StemPlus Orthopedics · 2003 · 2 generations on29descendants
- K092331Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;Encore Medical L.P. · 2010 · cites it directly27descendants
- K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A. · 2012 · 2 generations on13descendants
- K151739Revision Femoral StemLima Corporate S.P.A. · 2015 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955296 | Link MP Reconstruction Hip | Link America, Inc. | 1996 | 21 |
| 0 (this device) | K994126 | Modular-Plus Revision Stem | Plus Orthopedics | 2000 | — |
| +1 | K030971 | Modification to Modular Plus Revision Stem | Plus Orthopedics | 2003 | — |
| +2 | K032709 | Modular Plus Hip Stem | Plus Orthopedics | 2003 | — |
| +1 | K092331 | Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200… | Encore Medical L.P. | 2010 | 1 |
| +2 | K112158 | Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock… | Lima Corporate S.P.A. | 2012 | — |
| +2 | K151739 | Revision Femoral Stem | Lima Corporate S.P.A. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K955296 | Link MP Reconstruction HipSummary page 1…Revision Stem Hip Stem Prosthesis Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis 21 CFR 888.3360 (87J . wa LINK MP Reconstruction Hip Stem (K-955296, SE date 02/14/96) The MODULAR-PLUS Revision Stem is a cement-less, two-part modular system that consists of a distal anchorage… | 1996 |
What descends from it? (32)
See all 324 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?
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 MODULAR-PLUS® Revision Stem is intended for cementless use in fractures of the femur where a long section of bone is damaged and the stem must anchor into the distal half of the femur.
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/K994126 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994126: Modular-Plus Revision Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994126
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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