510(k) · Cleared
Recalled · Class II · 2023Porous Patella
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Medical, L.P. Dba Djo Surgical · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Jan 20, 2022 as substantially equivalent to K132624 (Stryker Orthopaedics, 2013) after a 127-day review. Its family tree reaches back 6 generations to 1995. 1 later device descends from it. It has been recalled once.
- Decided
- Jan 20, 2022
- Review
- 127 days
- Class
- Class II
- Product code
- MBH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K933785 (1995). 17 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 5 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- 4 generations backK031061 Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc. · 2003 · Recalled
- 3 generations backK072160 Nexgen Trabecular Metal Tibial TrayZimmer, Inc. · 2007 · Recalled
- 2 generations backK123486 Triathlon Tritanium Tibial BaseplateStryker · 2013 · Recalled
- 1 generation backK132624 Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics · 2013 · Recalled
- This deviceK212941 Porous PatellaEncore Medical, L.P. Dba Djo Surgical · 2022
- Descendant · cites it directly · 0 of its ownK243656 U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation · 2025
Most influential descendants
Showing 1 of 1 · See all- K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933785 | Next Generation Knee System | Zimmer, Inc. | 1995 | 83 |
| −5 | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | Zimmer, Inc. | 2002 | 6 |
| −4 | K031061 | Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components | Zimmer, Inc. | 2003 | 24 |
| −3 | K072160 | Nexgen Trabecular Metal Tibial Tray | Zimmer, Inc. | 2007 | 1 |
| −2 | K123486 | Triathlon Tritanium Tibial Baseplate | Stryker | 2013 | 7 |
| −1 | K132624 | Triathlon Tritanium Metal-Backed Patella | Stryker Orthopaedics | 2013 | 1 |
| 0 (this device) | K212941 | Porous Patella | Encore Medical, L.P. Dba Djo Surgical | 2022 | — |
| +1 | K243656 | U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella | United Orthopedic Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K132624 | Triathlon Tritanium Metal-Backed PatellaSummary page 4…er porous-coated uncemented prosthesis (888.3565) Regulatory Class: II Product Code(s): MBH, JWH III. PREDICATE DEVICE Stryker Triathlon Tritanium Metal-Backed Patella, K132624 The following reference devices are used: Encore Medical Moderately Cross Linked Patella with Vitamin E, K113756 Encore Orth… | 2013 |
| † | K113756 | Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly… | 2012 |
| † | K932246 | Foundation Metal-Backed Patella | 1994 |
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 |
|---|---|---|---|
| K243656 | U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 28, 2023 | Class II | Z-1384-2023 | Process change control | Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porous patella overdrills are marked with incorrect diameter size of 5.4 mm, when they should be 5.6 mm. If the incorrect drill is selected during… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 16 of the 17 ancestors have a recall of any class.
- Of its descendants, K243656 (United Orthopedic Corporation, 2025) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K132624.
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. 2022, 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 (151 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 FOUNDATION® Porous Coated Femur, FOUNDATION® Porous Coated Tibia Stemmed, FK/3DKNEE™ Porous Coated Downsize Tibia, 3DKNEE™ Porous Coated Femur, 3DKNEE™ Porous Coated Tibia, EMPOWR Porous® Knee Femur, EMPOWR Porous® Knee Tibia and Patella — Metal Backed 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212941 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212941: Porous Patella.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212941
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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