510(k) · Cleared
Recalled · Class II · 2022Empowr VVC Tibial Insert
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 9, 2018 as substantially equivalent to K160342 (Encore Medical L.P., 2016) and 2 other predicates after a 90-day review. Its family tree reaches back 10 generations to 1981. 3 later devices descend from it. It has been recalled once.
- Decided
- Jul 9, 2018
- Review
- 90 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 10 generations to K810258 (1981). 50 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 6 generations between
- 3 generations backK121727 Movation Knee SystemEncore Medical L.P. · 2012
- 2 generations backK143242 Rebel 3DKNEE SystemEncore Medical L.P. · 2015 · Recalled
- 1 generation backK160342 EMPOWR PS Knee SystemEncore Medical L.P. · 2016 · Recalled
- This deviceK180930 Empowr VVC Tibial InsertEncore Medical L.P. · 2018
- Descendant · cites it directly · 2 of its ownK230169 EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial InsertEncore Medical, L.P Dba Enovis · 2023
- Descendant · 2 generations on · 0 of its ownK251776 EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)Encore Medical L.P. · 2025
- Descendant · 2 generations on · 0 of its ownK251241 EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P. · 2025
Show all 10 generations
- Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 9 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 8 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 7 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
- 6 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
- 5 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
- 4 generations backK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled
- 3 generations backK121727 Movation Knee SystemEncore Medical L.P. · 2012
- 2 generations backK143242 Rebel 3DKNEE SystemEncore Medical L.P. · 2015 · Recalled
- 1 generation backK160342 EMPOWR PS Knee SystemEncore Medical L.P. · 2016 · Recalled
- This deviceK180930 Empowr VVC Tibial InsertEncore Medical L.P. · 2018
Most influential descendants
Showing 3 of 3 · See all- K230169EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial InsertEncore Medical, L.P Dba Enovis · 2023 · cites it directly2descendants
- K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)Encore Medical L.P. · 2025 · 2 generations on0descendants
- K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −9 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −8 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −7 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
| −6 | K070364 | 100KGY E-Poly Maxrom Acetabular Liners | Biomet, Inc. | 2007 | — |
| −5 | K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | 2008 | — |
| −4 | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 | Encore Medical L.P. | 2010 | 4 |
| −3 | K121727 | Movation Knee System | Encore Medical L.P. | 2012 | — |
| −2 | K143242 | Rebel 3DKNEE System | Encore Medical L.P. | 2015 | 17 |
| −1 | K160342 | EMPOWR PS Knee System | Encore Medical L.P. | 2016 | 5 |
| 0 (this device) | K180930 | Empowr VVC Tibial Insert | Encore Medical L.P. | 2018 | — |
| +1 | K230169 | EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert | Encore Medical, L.P Dba Enovis | 2023 | — |
| +2 | K251776 | EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) | Encore Medical L.P. | 2025 | — |
| +2 | 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 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K160342 | EMPOWR PS Knee SystemSummary page 5…ts. K180930 - Page 2 of 2 Predicate Devices: • EMPOWR PS Knee System (K160342) • Exprt Knee System (K140830) • Foundation Constrained Posterior Stabilized Tibial Insert (K933539) Reference Devices: •… | 2016 |
| * | K140830 | Exprt Revision KneeSummary page 5…K180930 - Page 2 of 2 Predicate Devices: • EMPOWR PS Knee System (K160342) • Exprt Knee System (K140830) • Foundation Constrained Posterior Stabilized Tibial Insert (K933539) Reference Devices: • Encore Medical Acetabular Syste… | 2014 |
| * | K933539 | Foundation Posterior Stabilized KneeSummary page 5…0930 - Page 2 of 2 Predicate Devices: • EMPOWR PS Knee System (K160342) • Exprt Knee System (K140830) • Foundation Constrained Posterior Stabilized Tibial Insert (K933539) Reference Devices: • Encore Medical Acetabular System (K072154) • Highly Cross-Linked Vitamin E UHMWPE Tibial Insert (K091… | 1994 |
| † | K072154 | Foundation (FMP) Porous Coated Spiked Acetabular System | 2007 |
| † | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 | 2010 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230169 | EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert | 2023 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 22, 2022 | Class II | Z-1187-2023 | Labeling Change Control | Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If the incorrect labeling is identified this could lead to surgical delay and if the surgeon does not recognize the size discrepancy between the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 37 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 22 of the 50 ancestors have a recall of any class.
- Of its descendants, K230169 (Encore Medical, L.P Dba Enovis, 2023) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K160342.
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. 2018, 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 patellofemoral erosion, dysfunction or prior patellectomy; • moderate valgus, varus or flexion deformities; • treatment of fractures that are unmanageable using other techniques. This device may also be…
Read the full statement (129 words)
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 patellofemoral erosion, dysfunction or prior patellectomy;
• moderate valgus, varus or flexion deformities;
• treatment of fractures that are unmanageable using other techniques.
This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the 3DKNEE™ Porous Coated Femur, EMPOWR Porous™ Knee Femur and EMPOWR Porous™ Knee Tibia which are intended for cementless applications.
While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180930 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180930: Empowr VVC Tibial Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180930
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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