510(k) · Cleared
Recalled · Class II · 2020EMPOWR Partial Knee
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Medical L.P. · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on Jul 16, 2019 as substantially equivalent to K033363 (Zimmer, Inc., 2004) after a 61-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jul 16, 2019
- Review
- 61 days
- Class
- Class II
- Product code
- HSX
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K880155 (1988). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK880155 Miller/Galante Precoat Unicompartmental KneeZimmer, Inc. · 1988 · Recalled
- 1 generation backK033363 Zimmer Unicompartmental Knee SystemZimmer, Inc. · 2004 · Recalled
- This deviceK191325 EMPOWR Partial KneeEncore Medical L.P. · 2019
- Descendant · cites it directly · 0 of its ownK211471 Balanced Knee System UniOrtho Development Corporation · 2021
Most influential descendants
Showing 1 of 1 · See all- K211471Balanced Knee System UniOrtho Development Corporation · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K880155 | Miller/Galante Precoat Unicompartmental Knee | Zimmer, Inc. | 1988 | 1 |
| −1 | K033363 | Zimmer Unicompartmental Knee System | Zimmer, Inc. | 2004 | 3 |
| 0 (this device) | K191325 | EMPOWR Partial Knee | Encore Medical L.P. | 2019 | — |
| +1 | K211471 | Balanced Knee System Uni | Ortho Development Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 HSX? 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 HSX device
- #1 K261609 Freedom Partial Knee Systemscore 15.1 · 12 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.
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 |
|---|---|---|---|
| K211471 | Balanced Knee System Uni | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 19, 2020 | Class II | Z-0480-2021 | Other | There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The extended length of the… |
| Jun 19, 2020 | Class II | Z-0479-2021 | Other | There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The extended length of the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 2 companies; a new generation was cleared every 15.5 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K211471 (Ortho Development Corporation, 2021) has gone furthest, with 0 descendants of its own.
- 21 other devices also cite its predicate K033363.
How does its category compare?
All HSX devicesHSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · HSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSX
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSX
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSX
175in 2025
MAUDE reports naming product code HSX, 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 | 6 | 33 | 0 | 6 |
| 2008 | 4 | 102 | 0 | 4 |
| 2009 | 2 | — | 49 | 21 |
| 2010 | 3 | 74 | 0 | 58 |
| 2011 | 1 | — | 0 | 114 |
| 2012 | 5 | 88 | 0 | 83 |
| 2013 | 2 | — | 1 | 79 |
| 2014 | 0 | — | 0 | 66 |
| 2015 | 1 | — | 0 | 57 |
| 2016 | 3 | 147 | 1 | 107 |
| 2017 | 5 | 160 | 4 | 113 |
| 2018 | 2 | — | 0 | 159 |
| 2019 | 7 | 90 | 0 | 177 |
| 2020 | 4 | 40 | 2 | 273 |
| 2021 | 7 | 81 | 0 | 240 |
| 2022 | 2 | — | 0 | 257 |
| 2023 | 1 | — | 0 | 231 |
| 2024 | 4 | 133 | 0 | 172 |
| 2025 | 4 | 59 | 0 | 175 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The EMPOWR Partial Knee System is indicated for patients with:
• Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
• Previous tibial condyle or plateau fractures with loss of anatomy or function.
• Varus or valgus deformities.
• Revision procedures where other treatments or devices have failed.
• These devices are indicated for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191325 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191325: EMPOWR Partial Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191325
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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