# K060303: Vanguard PS Open Box Porous Femoral Components

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Mar 30, 2006 after 52 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K915132 (1992). 18 ancestors in all.
47 later devices descend from it; 2 cite it directly.
0 of 66 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.
- K033489: Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim Accel Knee System Also Known, Biomet, Inc. (2004) Summary page 1.

## Most influential descendants
- K113550: Vanguard Complete Knee System (2012), 46 descendants of its own
- K221479: Persona Personalized Knee System (2022), 8 descendants of its own
- K151266: Physica CR Knee System (2015), 8 descendants of its own
- K152008: Physica PS Knee System (2015), 7 descendants of its own
- K193284: Physica LMC Knee System (2020), 6 descendants of its own

## Indications for use
The VanguardTM PS Open Box Porous Femoral Components are indicated for cemented or non-cemented use in cases of: 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. The device is a single use implant.

Source page: https://510kreport.com/device/K060303
Methodology: https://510kreport.com/methodology