# K080528: E-Poly Tibial Bearings

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Orthopedics, Inc.
- Decided: Jun 17, 2008 after 112 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K810258 (1981). 20 ancestors in all.
248 later devices descend from it; 6 cite it directly.
0 of 269 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023546: Maxim Accel Knee System, Biomet, Inc. (2003) Summary page 1.
- K041046: Maxim Accel (Vanguard) PS+ Bearings, Biomet, Inc. (2004) Summary page 1.
- K050222: Vanguard Anterior Stabilized Tibial Bearings, Biomet, Inc. (2005) Summary page 1.
- K070364: 100KGY E-Poly Maxrom Acetabular Liners, Biomet, Inc. (2007) 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
- K100048: E1 Antioxidant Infused Technology (2010), 114 descendants of its own
- K120370: Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners (2012), 88 descendants of its own
- K121771: Zimmer Persona the Personalized Knee System (2012), 59 descendants of its own
- K113550: Vanguard Complete Knee System (2012), 46 descendants of its own

## Indications for use
1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. For cemented and un-cemented use.

Source page: https://510kreport.com/device/K080528
Methodology: https://510kreport.com/methodology