510(k) · Cleared
Recalled · Class II · 2015Exprt Revision Knee
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Medical L.P. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jul 11, 2014 as substantially equivalent to K933539 (Encore Orthopedics, Inc., 1994) and 3 other predicates after a 100-day review. Its family tree reaches back 8 generations to 1981. 7 later devices descend from it. It has been recalled once.
- Decided
- Jul 11, 2014
- Review
- 100 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 8 generations to K810258 (1981). 47 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 7 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 6 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 5 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
- 4 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
- 3 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
- 2 generations backK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled
- 1 generation backK121727 Movation Knee SystemEncore Medical L.P. · 2012
- This deviceK140830 Exprt Revision KneeEncore Medical L.P. · 2014
- Descendant · cites it directly · 3 of its ownK180930 Empowr VVC Tibial InsertEncore Medical L.P. · 2018 · Recalled
- Descendant · 2 generations on · 2 of its ownK230169 EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial InsertEncore Medical, L.P Dba Enovis · 2023
- Descendant · cites it directly · 1 of its ownK213793 EMPOWR Revision KneeEncore Medical L.P. · 2022
- Descendant · 3 generations on · 0 of its ownK251776 EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)Encore Medical L.P. · 2025
- Descendant · 3 generations on · 0 of its ownK251241 EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K180930Empowr VVC Tibial InsertEncore Medical L.P. · 2018 · cites it directly3descendants
- K230169EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial InsertEncore Medical, L.P Dba Enovis · 2023 · 2 generations on2descendants
- K213793EMPOWR Revision KneeEncore Medical L.P. · 2022 · cites it directly1descendant
- K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)Encore Medical L.P. · 2025 · 3 generations on0descendants
- K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −7 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −6 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −5 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
| −4 | K070364 | 100KGY E-Poly Maxrom Acetabular Liners | Biomet, Inc. | 2007 | — |
| −3 | K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | 2008 | — |
| −2 | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 | Encore Medical L.P. | 2010 | 4 |
| −1 | K121727 | Movation Knee System | Encore Medical L.P. | 2012 | — |
| 0 (this device) | K140830 | Exprt Revision Knee | Encore Medical L.P. | 2014 | — |
| +1 | K180930 | Empowr VVC Tibial Insert | Encore Medical L.P. | 2018 | 1 |
| +2 | K230169 | EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert | Encore Medical, L.P Dba Enovis | 2023 | — |
| +1 | K213793 | EMPOWR Revision Knee | Encore Medical L.P. | 2022 | — |
| +3 | K251776 | EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) | Encore Medical L.P. | 2025 | — |
| +3 | K251241 | EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) | Encore Medical L.P. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 7 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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 JWH? 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 JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K933539 | Foundation Posterior Stabilized KneeSummary page 1…lvage of previously failed surgical attempts. This system is to be used for cemented applications Predicate Devices: DJO Surgical Foundation PS Knee System - K(933539 DJO Surgical Movation Knee System - K(100900, K1 21727 DJO Surgical e+ EMP… | 1994 |
| * | K100900 | Motivation Knee SystemSummary page 1…for cemented applications Predicate Devices: DJO Surgical Foundation PS Knee System - K(933539 DJO Surgical Movation Knee System - K(100900, K1 21727 DJO Surgical e+ EMP Acetabular Liner (Accessory Sterilization) - KI 30365… | 2010 |
| * | K121727 | Movation Knee SystemSummary page 1…ented applications Predicate Devices: DJO Surgical Foundation PS Knee System - K(933539 DJO Surgical Movation Knee System - K(100900, K1 21727 DJO Surgical e+ EMP Acetabular Liner (Accessory Sterilization) - KI 30365… | 2012 |
| * | K130365 | X-Alt Highly Cross Linked VE Acetabular Liner | 2013 |
What descends from it? (7)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 16, 2015 | Class II | Z-0165-2016 | Labeling design | The labeling is missing the size/diameter information. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 19 of the 47 ancestors have a recall of any class.
- Of its descendants, K180930 (Encore Medical L.P., 2018) has gone furthest, with 3 descendants of its own.
- 7 other devices also cite its predicate K933539.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, 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 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
Joint replacement is indicated for patients suffering from disability due to:
*degenerative, post-traumatic or rheumatoid arthritis;
*avascular necrosis of the femoral condyle;
*post-traumatic loss of joint configuration, particularly when there is patellofemaral erosion,
dysfunction or prior patellectomy,
*moderate valgus, vanas or flexion deformities;
*treatment of fractures that are unmanageable using other techniques.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s).
This device may also be indicated in the salvage of previously failed surgical attempts. This
system is to be used for cemented applications
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140830 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140830: Exprt Revision Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140830
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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