# K212941: Porous Patella

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical, L.P. Dba Djo Surgical
- Decided: Jan 20, 2022 after 127 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K933785 (1995). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132624: Triathlon Tritanium Metal-Backed Patella, Stryker Orthopaedics (2013) Summary page 4.

## Most influential descendants
- K243656: U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella (2025), 0 descendants of its own

## Recalls of this device
- Feb 28, 2023 · Class II · Z-1384-2023: 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 

## Indications for use
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.

Source page: https://510kreport.com/device/K212941
Methodology: https://510kreport.com/methodology