# K103223: Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Dec 21, 2010 after 50 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K810258 (1981). 25 ancestors in all.
37 later devices descend from it; 2 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091956: Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712, Encore Medical L.P. (2010) Summary page 1.

## Most influential descendants
- K122870: Itotal Cruciate Retaining (CR) Knee Replacement System (2013), 33 descendants of its own
- K131467: Itotal Cruciate Retaining (CR) Knee Replacement System (2013), 30 descendants of its own
- K131019: Itotal Cruciate Retaining (C) Knee Replacement System (2013), 30 descendants of its own
- K140833: Itotal Posterior Stabilized (PS) Knee Replacement System (2014), 26 descendants of its own
- K140423: Itotal Cruciate Retaining (CR) Knee Replacement System (2014), 25 descendants of its own

## 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 patellectomry; * 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. This device is intended to be used with the 3DKnee System for cemented or uncemented applications.

Source page: https://510kreport.com/device/K103223
Methodology: https://510kreport.com/methodology