510(k) · Cleared
ClearedEMPOWR 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 Apr 1, 2022 as substantially equivalent to K160342 (Encore Medical L.P., 2016) and 2 other predicates after a 116-day review. Its family tree reaches back 10 generations to 1981. 1 later device descends from it.
- Decided
- Apr 1, 2022
- Review
- 116 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K810258 (1981). 51 ancestors in all. 1 later device descends 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 deviceK213793 EMPOWR Revision KneeEncore Medical L.P. · 2022
- Descendant · cites it directly · 0 of its ownK230441 EMPOWR Stem Extender, 50mmEncore Medical, L.P Dba Enovis · 2023
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 deviceK213793 EMPOWR Revision KneeEncore Medical L.P. · 2022
Most influential descendants
Showing 1 of 1 · See all- K230441EMPOWR Stem Extender, 50mmEncore Medical, L.P Dba Enovis · 2023 · cites it directly0descendants
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) | K213793 | EMPOWR Revision Knee | Encore Medical L.P. | 2022 | — |
| +1 | K230441 | EMPOWR Stem Extender, 50mm | Encore Medical, L.P Dba Enovis | 2023 | — |
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 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 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 4…rotibial polymer/metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3560) Regulatory Class: II Product Code: JWH III. PREDICATE DEVICE DJO EMPOWR PS Knee®, K160342 DJO EMPOWR® Universal Tibial Baseplate, K173723 DJO EXPRT® Femoral Augment, K140830 Several reference devices are used to suppor… | 2016 |
| * | K173723 | EMPOWR Universal Tibial BaseplateSummary page 4…cemented prosthesis (21 CFR 888.3560) Regulatory Class: II Product Code: JWH III. PREDICATE DEVICE DJO EMPOWR PS Knee®, K160342 DJO EMPOWR® Universal Tibial Baseplate, K173723 DJO EXPRT® Femoral Augment, K140830 Several reference devices are used to support minor differences in technological features.… | 2018 |
| * | K140830 | Exprt Revision KneeSummary page 4…) Regulatory Class: II Product Code: JWH III. PREDICATE DEVICE DJO EMPOWR PS Knee®, K160342 DJO EMPOWR® Universal Tibial Baseplate, K173723 DJO EXPRT® Femoral Augment, K140830 Several reference devices are used to support minor differences in technological features. IV. DEVICE DESCRIPTION EMPOWR Revis… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230441 | EMPOWR Stem Extender, 50mm | 2023 | 0 |
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 41 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 23 of the 51 ancestors have a recall of any class.
- Of its descendants, K230441 (Encore Medical, L.P Dba Enovis, 2023) has gone furthest, with 0 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. 2022, 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 (132 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 3DKNEE™ POROUS Femur, 3DKNEE™ Porous Coated Tibia, and EMPOWR POROUS 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/K213793 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213793: EMPOWR 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/K213793
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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