# K113756: Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly Cross Linked VE Metal Backed PA

- Pathway: 510(k) (Special)
- Applicant: Encore Medical L.P.
- Decided: Mar 14, 2012 after 84 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K810258 (1981). 41 ancestors in all.
35 later devices descend from it; 2 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932246: Foundation Metal-Backed Patella, Encore Orthopedics, Inc. (1994) Summary page 1.
- K905613: MTS Knee System, T & R Mfg., Inc. (1991) Summary page 1.
- K100900: Motivation Knee System, Encore Medical L.P. (2010) Summary page 1.
- 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

## Recalls of this device
- Oct 5, 2023 · Class II · Z-0626-2024: Mislabeling

## 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. This system is to be used for cemented applications

Source page: https://510kreport.com/device/K113756
Methodology: https://510kreport.com/methodology