510(k) · Cleared
Recalled · Class II · 2023EMPOWR Porous Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Medical L.P. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Oct 4, 2017 as substantially equivalent to K143242 (Encore Medical L.P., 2015) and 1 other predicate after a 93-day review. Its family tree reaches back 9 generations to 1981. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Oct 4, 2017
- Review
- 93 days
- Class
- Class II
- Product code
- MBH
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 9 generations to K810258 (1981). 43 ancestors in all. 1 later device descends from it, 1 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 deviceK171991 EMPOWR Porous Knee SystemEncore Medical L.P. · 2017
- Descendant · cites it directly · 0 of its ownK210308 EMPOWR Porous Femur with HAnano SurfaceTMEncore Medical L.P. · 2021
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 deviceK171991 EMPOWR Porous Knee SystemEncore Medical L.P. · 2017
Most influential descendants
Showing 1 of 1 · See all- K210308EMPOWR Porous Femur with HAnano SurfaceTMEncore Medical L.P. · 2021 · cites it directly0descendants
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) | K171991 | EMPOWR Porous Knee System | Encore Medical L.P. | 2017 | — |
| +1 | K210308 | EMPOWR Porous Femur with HAnano SurfaceTM | Encore Medical L.P. | 2021 | — |
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 | 2 | 0 |
| 2005 | 1 | 0 |
| 2010 | 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 MBH? 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 MBH device
- #1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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…Porous-Coated MBH Uncemented Prosthesis Description: The EMPOWR POROUS KNEE System is a line extension to the EMPOWR Knee platform (cleared via K143242), to include porous coated femoral and tibial baseplate implants and instruments, which provide surgeons with comprehensive surg… | 2015 |
| * | K032905 | 3DKNEE Porous Coated Femoral ComponentSummary page 5…K171991 page 2 of 2 Predicate Devices: • Empowr Knee System (K143242) • 3DKnee Porous Femur (K032905) • FMP™ Porous Coated Acetabular Shells (K072888) Comparable Features to Predicate Device(s): The EMPOWR POROUS KNE… | 2004 |
| † | K072888 | Revelation and Linear Hip Stems and FMP Acetabular Shells (Spiked, Hemispherical and… | 2008 |
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 |
|---|---|---|---|
| K210308 | EMPOWR Porous Femur with HAnano SurfaceTM | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 10, 2023 | Class II | Z-0508-2024 | Labeling Change Control | Due to incorrect product/device within packaging. |
| Sep 29, 2023 | Class II | Z-0258-2024 | Process change control | Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery. |
| Aug 3, 2020 | Class II | Z-0060-2021 | Process change control | There is a potential for the retaining pin of the tibial punch handle to become loose and fall out while impacting. If undetected, there is a potential of leaving debris in the joint space. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 19 of the 43 ancestors have a recall of any class.
- Of its descendants, K210308 (Encore Medical L.P., 2021) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K143242.
How does its category compare?
All MBH devicesMBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MBH
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBH
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBH
1in 2024
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · MBH
1,561in 2025
MAUDE reports naming product code MBH, 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 | 10 | 59 | 0 | 27 |
| 2008 | 3 | 70 | 0 | 21 |
| 2009 | 3 | 209 | 2 | 89 |
| 2010 | 4 | 84 | 0 | 121 |
| 2011 | 5 | 84 | 15 | 247 |
| 2012 | 5 | 90 | 1 (1) | 370 |
| 2013 | 6 | 138 | 4 (4) | 308 |
| 2014 | 9 | 114 | 0 | 385 |
| 2015 | 8 | 100 | 0 | 955 |
| 2016 | 4 | 74 | 1 | 1,034 |
| 2017 | 4 | 115 | 9 | 1,007 |
| 2018 | 6 | 89 | 1 | 1,191 |
| 2019 | 1 | — | 1 | 1,394 |
| 2020 | 7 | 112 | 2 | 1,089 |
| 2021 | 6 | 48 | 0 | 1,539 |
| 2022 | 7 | 57 | 0 | 1,261 |
| 2023 | 6 | 94 | 2 | 1,263 |
| 2024 | 10 | 84 | 1 | 1,497 |
| 2025 | 8 | 98 | 0 | 1,561 |
| 2026 | 7 | 153 | 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 (104 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 3DKNEE™ Porous Tibia which are intended for cementless applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171991 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171991: EMPOWR Porous 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/K171991
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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