510(k) · Cleared
Cleared3DKNEE Porous Coated Femoral Component
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Orthopedics, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Jul 6, 2004 as substantially equivalent to K020114 (Encore Orthopedics, Inc., 2002) after a 293-day review. Its family tree reaches back 2 generations to 1993. 2 later devices descend from it.
- Decided
- Jul 6, 2004
- Review
- 293 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K923277 (1993). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK923277 Foundation Knee SystemEncore Orthopedics, Inc. · 1993 · Recalled
- 1 generation backK020114 3D KNEEEncore Orthopedics, Inc. · 2002 · Recalled
- This deviceK032905 3DKNEE Porous Coated Femoral ComponentEncore Orthopedics, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK171991 EMPOWR Porous Knee SystemEncore Medical L.P. · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK210308 EMPOWR Porous Femur with HAnano SurfaceTMEncore Medical L.P. · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923277 | Foundation Knee System | Encore Orthopedics, Inc. | 1993 | 4 |
| −1 | K020114 | 3D KNEE | Encore Orthopedics, Inc. | 2002 | 5 |
| 0 (this device) | K032905 | 3DKNEE Porous Coated Femoral Component | Encore Orthopedics, Inc. | 2004 | — |
| +1 | K171991 | EMPOWR Porous Knee System | Encore Medical L.P. | 2017 | 3 |
| +2 | 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 |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K020114 | 3D KNEESummary page 1…ght configurations. The femoral component is designed to match the condyles of the tibial insert for greater congruency and is the same design as the 3DKneCTM cleared in K0201 14. Substantial Equivalence The 3DKneeTM porous femoral component is similar in design, materials and indications to the 3DKneeTM (… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171991 | EMPOWR Porous Knee System | 2017 | 1 |
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 11 years and passes through 1 company; a new generation was cleared every 9.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K171991 (Encore Medical L.P., 2017) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K020114.
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.
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?
This device is part of a total knee replacement system utilized in treating patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function. • Noninflammatory degenerative joint disease including osteoarthritis or traumatic arthritis • Avascular necrosis of…
Read the full statement (108 words)
This device is part of a total knee replacement system utilized in treating patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function.
• Noninflammatory degenerative joint disease including osteoarthritis or traumatic 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
• Rheumatoid arthritis
• Treatment of fractures that are unmanageable using other techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032905 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032905: 3DKNEE Porous Coated Femoral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032905
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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