# K091956: Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Sep 28, 2010 after 454 days
- Product code: OIY (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K810258 (1981). 24 ancestors in all.
119 later devices descend from it; 9 cite it directly.
0 of 144 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.
- K080528: E-Poly Tibial Bearings, Biomet Orthopedics, Inc. (2008) Summary page 1.

## Most influential descendants
- 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
- K113756: Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly Cross Linked VE Metal Backed PA (2012), 35 descendants of its own
- K162024: AltiVate Anatomic Shoulder System (2016), 34 descendants of its own

## Recalls of this device
- May 31, 2017 · Class II · Z-2659-2017: Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert.
- May 31, 2017 · Class II · Z-2658-2017: Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert.
- Apr 1, 2013 · Class II · Z-1213-2013: U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished
- Aug 9, 2012 · Class II · Z-2302-2012: The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be expi

## 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 ipatellofemoral erosion, dysfunction or prior patellectomny; * moderate valgus, varus or flexion deformities; This device may also be indicated in the salvage of previously failed surgical attempts. This device is intended to be used with the 3DKnee System for cemented or uncemented applications.

Source page: https://510kreport.com/device/K091956
Methodology: https://510kreport.com/methodology