# K020114: 3D KNEE

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Jul 12, 2002 after 182 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923277 (1993). 2 ancestors in all.
143 later devices descend from it; 7 cite it directly.
0 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923277: Foundation Knee System, Encore Orthopedics, Inc. (1993) Summary page 1.
- K000590: Lateral Pivot Insert, Encore Orthopedics, Inc. (2000) Summary page 1.

## Most influential descendants
- K091956: Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 (2010), 119 descendants of its own
- K100900: Motivation Knee System (2010), 72 descendants of its own
- K130365: X-Alt Highly Cross Linked VE Acetabular Liner (2013), 38 descendants of its own
- K103223: Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts (2010), 37 descendants of its own
- K123982: Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+ (2013), 35 descendants of its own

## Recalls of this device
- Jun 28, 2010 · Not classified · Z-2244-2010: One lot of product has an incorrect color label. The color label is a secondary visual indicator of sizing.
- Mar 19, 2010 · Not classified · Z-1433-2010: Affected product had incorrect color label which is a secondary visual indicator for sizing.
- Feb 20, 2008 · Not classified · Z-1539-2008: Tibial insert trial incorrectly marked for thickness; device thickness marked correctly as 13mm on the underside of the trial, but is incorrectly marked as 15mm on the side.
- Nov 3, 2005 · Not classified · Z-0332-06: The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring 
- May 10, 2004 · Not classified · Z-1011-04: Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE

## Indications for use
This device is part of a total knee replacement system utilized in treating patients who are candidates for primary cemented 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/K020114
Methodology: https://510kreport.com/methodology