510(k) · Cleared
ClearedEMPOWR Stem Extender, 50mm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Medical, L.P Dba Enovis · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Mar 17, 2023 as substantially equivalent to K213793 (Encore Medical L.P., 2022) after a 24-day review. Its family tree reaches back 11 generations to 1981.
- Decided
- Mar 17, 2023
- Review
- 24 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K810258 (1981). 52 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 7 generations between
- 3 generations backK143242 Rebel 3DKNEE SystemEncore Medical L.P. · 2015 · Recalled
- 2 generations backK160342 EMPOWR PS Knee SystemEncore Medical L.P. · 2016 · Recalled
- 1 generation backK213793 EMPOWR Revision KneeEncore Medical L.P. · 2022
- This deviceK230441 EMPOWR Stem Extender, 50mmEncore Medical, L.P Dba Enovis · 2023
Show all 11 generations
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 10 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 9 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 8 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
- 7 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
- 6 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
- 5 generations backK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled
- 4 generations backK121727 Movation Knee SystemEncore Medical L.P. · 2012
- 3 generations backK143242 Rebel 3DKNEE SystemEncore Medical L.P. · 2015 · Recalled
- 2 generations backK160342 EMPOWR PS Knee SystemEncore Medical L.P. · 2016 · Recalled
- 1 generation backK213793 EMPOWR Revision KneeEncore Medical L.P. · 2022
- This deviceK230441 EMPOWR Stem Extender, 50mmEncore Medical, L.P Dba Enovis · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −10 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −9 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −8 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
| −7 | K070364 | 100KGY E-Poly Maxrom Acetabular Liners | Biomet, Inc. | 2007 | — |
| −6 | K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | 2008 | — |
| −5 | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 | Encore Medical L.P. | 2010 | 4 |
| −4 | K121727 | Movation Knee System | Encore Medical L.P. | 2012 | — |
| −3 | K143242 | Rebel 3DKNEE System | Encore Medical L.P. | 2015 | 17 |
| −2 | K160342 | EMPOWR PS Knee System | Encore Medical L.P. | 2016 | 5 |
| −1 | K213793 | EMPOWR Revision Knee | Encore Medical L.P. | 2022 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K213793 | EMPOWR Revision KneeSummary page 4…emi-constrained cemented prosthesis per 21 CFR 888.3560 Regulatory Class: II Primary Product Code: JWH III. PREDICATE DEVICE EMPOWR Revision Knee (K213793) IV. DEVICE DESCRIPTION The EMPOWR Stem Extender, 50mm implant is a modular accessory of the EMPOWR Revision Knee (K213793). Wh… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 42 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 23 of the 52 ancestors have a recall of any class.
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. 2023, 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/K230441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230441: EMPOWR Stem Extender, 50mm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230441
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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