# K032905: 3DKNEE Porous Coated Femoral Component

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Jul 6, 2004 after 293 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K923277 (1993). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020114: 3D KNEE, Encore Orthopedics, Inc. (2002) Summary page 1.

## Most influential descendants
- K171991: EMPOWR Porous Knee System (2017), 1 descendant of its own
- K210308: EMPOWR Porous Femur with HAnano SurfaceTM (2021), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K032905
Methodology: https://510kreport.com/methodology