# K033489: Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim Accel Knee System Also Known

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jun 2, 2004 after 211 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: 2 generations back to K915132 (1992). 17 ancestors in all.
60 later devices descend from it; 9 cite it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K833921: Agc Total Knee Prosthesis, Biomet, Inc. (1984) Summary page 1.
- K912245: Agc Revision Knee Prothesis, Biomet, Inc. (1991) Summary page 1.
- K982869: Ascent System, Biomet, Inc. (1998) Summary page 1.
- K994326: Ascent Knee System, Biomet Manufacturing, Inc. (2000) Summary page 1.
- K915132: MCK Maximum Congruent Knee) Knee System, Biomet, Inc. (1992) Summary page 1.
- K023546: Maxim Accel Knee System, Biomet, Inc. (2003) Summary page 1.
- K031462: The Nexgen Knee System Uncemented Components, Implex Corp. (2003) Summary page 1.
- K030612: Genesis II Total Knee System, Smith & Nephew, Inc. (2003) Summary page 1.
- K030623: Smith & Nephew Profix Total Knee System, Smith & Nephew, Inc. (2003) Summary page 1.

## Most influential descendants
- K060303: Vanguard PS Open Box Porous Femoral Components (2006), 47 descendants of its own
- K113550: Vanguard Complete Knee System (2012), 46 descendants of its own
- K080361: Regenerex Tibial Components (2008), 13 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

## Indications for use
The indications for Biomet's Non-Cemented Porous Coated Knee Components include: 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 of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure

Source page: https://510kreport.com/device/K033489
Methodology: https://510kreport.com/methodology