510(k) · Cleared
ClearedEpf-Plus Cementless Press-Fit Acetabular Cup
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 Dec 11, 2000 as substantially equivalent to K972931 (Hhl Consulting, 1997) after a 369-day review. Its family tree reaches back 2 generations to 1996. 67 later devices descend from it.
- Decided
- Dec 11, 2000
- Review
- 369 days
- Class
- Class II
- Product code
- LWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K961526 (1996). 67 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK961526 Press-Fit Porous ShellEncore Orthopedics, Inc. · 1996
- 1 generation backK972931 Plus Epf Acetabular CupHhl Consulting · 1997
- This deviceK994146 Epf-Plus Cementless Press-Fit Acetabular CupPlus Orthopedics · 2000
- Descendant · cites it directly · 63 of its ownK011719 Plus Cancellous Bone ScrewsPlus Orthopedics · 2001
- Descendant · 2 generations on · 33 of its ownK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
- Descendant · 3 generations on · 32 of its ownK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 23 of its ownK091069 Medacta Bone Screws - Evolis and VersafitMedacta International S.A. · 2009
- Descendant · 3 generations on · 21 of its ownK103721 Mpact Acetabular SystemMedacta International · 2011
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 67 · See all- K011719Plus Cancellous Bone ScrewsPlus Orthopedics · 2001 · cites it directly63descendants
- K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013 · 2 generations on33descendants
- K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · 3 generations on32descendants
- K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A. · 2009 · 2 generations on23descendants
- K103721Mpact Acetabular SystemMedacta International · 2011 · 3 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961526 | Press-Fit Porous Shell | Encore Orthopedics, Inc. | 1996 | — |
| −1 | K972931 | Plus Epf Acetabular Cup | Hhl Consulting | 1997 | — |
| 0 (this device) | K994146 | Epf-Plus Cementless Press-Fit Acetabular Cup | Plus Orthopedics | 2000 | — |
| +1 | K011719 | Plus Cancellous Bone Screws | Plus Orthopedics | 2001 | — |
| +2 | K123055 | Smith & Nephew, Inc Screw and Plate System Instrumentation | Smith & Nephew, Inc. | 2013 | — |
| +3 | K140814 | Evos Mini-Fragment Plating System | Smith & Nephew, Inc. | 2014 | 2 |
| +2 | K091069 | Medacta Bone Screws - Evolis and Versafit | Medacta International S.A. | 2009 | — |
| +3 | K103721 | Mpact Acetabular System | Medacta International | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 8 | 0 |
| 2025 | 12 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K972931 | Plus Epf Acetabular CupSummary page 1…As a Class 1l medical device, guidance documents and special controls are in effect. Equivalent Legally Marketed Device(s): e PLUS EPF Acetabular Cup, Plus Orthopedics, K972931 The EPF®-PLus Cementless Press-Fit Acetabular Cup is substantially equivalent as a result of the use of identical materials, ide… | 1997 |
What descends from it? (67)
See all 673 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 4 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K011719 (Plus Orthopedics, 2001) has gone furthest, with 63 descendants of its own.
- 1 other device also cites its predicate K972931.
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 EPF®-PLUS Cementless Press-Fit Acetabular Cup is intended for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions.
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/K994146 · printed Nov 5, 2026
Cite this page
510(k) Report. “K994146: Epf-Plus Cementless Press-Fit Acetabular Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K994146
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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