510(k) · Cleared
ClearedEMPOWR 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 Dec 19, 2025 after a 93-day review. The summary cites 7 numbers, none of which could be confirmed as its predicate (see the table below).
- Decided
- Dec 19, 2025
- Review
- 93 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 7
The summary cites 7 numbers, none of which could be confirmed as its predicate (see the table below).
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? (7)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K143242 | FDA’s K143242 is Rebel 3DKNEE System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2015 |
| Kept off the family tree | K170573 | FDA’s K170573 is Empowr CR Knee Tibial Insert Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2017 |
| Kept off the family tree | K171991 | FDA’s K171991 is EMPOWR Porous Knee System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2017 |
| Kept off the family tree | K173723 | FDA’s K173723 is EMPOWR Universal Tibial Baseplate Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2018 |
| Kept off the family tree | K210308 | FDA’s K210308 is EMPOWR Porous Femur with HAnano SurfaceTM Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2021 |
| Kept off the family tree | K121835 | FDA’s K121835 is Domed Tri-Peg Patella, Highly Cross Linked Domed Tri-Peg Patella with VE Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2012 |
| Kept off the family tree | K212941 | FDA’s K212941 is Porous Patella Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2022 |
| † | K173890 | GMK Sphere - Kinematic Alignment | 2018 |
| † | K172524 | Zimmer Persona Personalized Knee System | 2018 |
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.
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. 2025, 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?
When a mechanical alignment approach is utilized, these devices are 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…
Read the full statement (205 words)
When a mechanical alignment approach is utilized, these devices are 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.
These devices may also be indicated in the salvage of previously failed surgical attempts.
When the EMPOWR® Dynamic Natural Alignment (DNA) approach is utilized, these devices are indicated for patients with disability due to:
• degenerative, post-traumatic or rheumatoid arthritis;
• avascular necrosis of the femoral condyle;
• moderate valgus, varus or flexion deformities.
All EMPOWR devices except for the EMPOWR Revision Knee TM, EMPOWR PS Knee TM, and EMPOWR Partial Knee TM may be implanted using the EMPOWR® Dynamic Natural Alignment (DNA) surgical technique.
All devices are intended for cemented applications except for the EMPOWR Porous® Knee Femur, EMPOWR Porous® Knee Tibia, and Porous Patella 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/K252974 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252974: EMPOWR Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252974
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026