510(k) · Cleared
Recalled · Class II · 2017EMPOWR PS Knee System
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 May 19, 2016 as substantially equivalent to K143242 (Encore Medical L.P., 2015) and 3 other predicates after a 101-day review. Its family tree reaches back 9 generations to 1981. 6 later devices descend from it. It has been recalled 5 times.
- Decided
- May 19, 2016
- Review
- 101 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 5
- Predicates
- 4
Its longest line of descent runs back 9 generations to K810258 (1981). 42 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 5 generations between
- 3 generations backK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled
- 2 generations backK121727 Movation Knee SystemEncore Medical L.P. · 2012
- 1 generation backK143242 Rebel 3DKNEE SystemEncore Medical L.P. · 2015 · Recalled
- This deviceK160342 EMPOWR PS Knee SystemEncore Medical L.P. · 2016
- 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
Show all 9 generations
- Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 8 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 7 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 6 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
- 5 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
- 4 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
- 3 generations backK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled
- 2 generations backK121727 Movation Knee SystemEncore Medical L.P. · 2012
- 1 generation backK143242 Rebel 3DKNEE SystemEncore Medical L.P. · 2015 · Recalled
- This deviceK160342 EMPOWR PS Knee SystemEncore Medical L.P. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · 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 |
|---|---|---|---|---|---|
| −9 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −8 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −7 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −6 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
| −5 | K070364 | 100KGY E-Poly Maxrom Acetabular Liners | Biomet, Inc. | 2007 | — |
| −4 | K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | 2008 | — |
| −3 | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 | Encore Medical L.P. | 2010 | 4 |
| −2 | K121727 | Movation Knee System | Encore Medical L.P. | 2012 | — |
| −1 | K143242 | Rebel 3DKNEE System | Encore Medical L.P. | 2015 | 17 |
| 0 (this device) | K160342 | EMPOWR PS Knee System | Encore Medical L.P. | 2016 | — |
| +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 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K143242 | Rebel 3DKNEE SystemSummary page 4…vity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Predicate Devices: EMPOWR Knee System – K143242 Foundation PS Knee System - K933539 Movation Knee System - K100900 & K121727… | 2015 |
| * | K933539 | Foundation Posterior Stabilized KneeSummary page 4…ns of restoring mobility and reducing pain for many patients. Predicate Devices: EMPOWR Knee System – K143242 Foundation PS Knee System - K933539 Movation Knee System - K100900 & K121727 Comparable Features to Predicate Device(s): This device is co… | 1994 |
| * | K100900 | Motivation Knee SystemSummary page 4…ents. Predicate Devices: EMPOWR Knee System – K143242 Foundation PS Knee System - K933539 Movation Knee System - K100900 & K121727 Comparable Features to Predicate Device(s): This device is comparable to the predicate devices in indications, mater… | 2010 |
| * | K121727 | Movation Knee SystemSummary page 4…edicate Devices: EMPOWR Knee System – K143242 Foundation PS Knee System - K933539 Movation Knee System - K100900 & K121727 Comparable Features to Predicate Device(s): This device is comparable to the predicate devices in indications, material, dimen… | 2012 |
What descends from it? (6)
2 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 15, 2017 | Class II | Z-0041-2018 | Packaging process control | It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707. |
| Sep 15, 2017 | Class II | Z-0042-2018 | Packaging process control | It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707. |
| Jan 10, 2017 | Class II | Z-1139-2017 | Component design/selection | The Empowr PS Insert was reported as missing the impaction slot feature. |
| Sep 19, 2016 | Class II | Z-0325-2017 | Under Investigation by firm | It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. The current design of the captured box cut guides can create an instance… |
| Sep 19, 2016 | Class II | Z-0766-2017 | Device Design | It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 19 of the 42 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.
- 3 other devices also cite its predicate K143242.
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. 2016, 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 indicated in…
Read the full statement (115 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 3SDKNEE™ Porous Coated Femur which is 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160342: EMPOWR PS Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160342
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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