# K050222: Vanguard Anterior Stabilized Tibial Bearings

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Aug 16, 2005 after 197 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- 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: 2 generations back to K915132 (1992). 3 ancestors in all.
255 later devices descend from it; 7 cite it directly.
0 of 259 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.

## Most influential descendants
- K080528: E-Poly Tibial Bearings (2008), 248 descendants of its own
- 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

## Recalls of this device
- Mar 13, 2024 · Class II · Z-1607-2024: Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.

## 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. Femoral components and tibial tray components with porous coating are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok®) devices and all polyethylene patellar components are indicated for cemented application only.

Source page: https://510kreport.com/device/K050222
Methodology: https://510kreport.com/methodology