# K061433: Vanguard Anatomic Patella Groove  (Apg) / Vanguard V Groove

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing, Inc.
- Decided: Aug 21, 2006 after 89 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). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 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.
- K040770: Vanguard Patella Components, Biomet Manufacturing, Inc. (2004) Summary page 1.
- K921182: Ultra High Molecular Weight Polyethylene Component, Biomet, Inc. (1993) Summary page 1.
- K041160: Avon Extra-Small Patello-Femoral Replacement, Howmedica Osteonics Corp. (2004) Summary page 1.
- K020841: Avon Patellar Component, Howmedica Osteonics Corp. (2002) Summary page 1.
- K051948: Avon Patello-Femoral Joint Prosthesis, Howmedica Osteonics Corp. (2005) Summary page 1.
- K872379: Insall/Burstein* II Modular Total Knee, Zimmer, Inc. (1987) Summary page 1.
- K874547: Kirschner Perform Total Knee System Porous Coated, Kirschner Medical Corp. (1987) Summary page 1.
- K972270: Nexgen Complete Knee Solution Convex Inset Patella Component, Zimmer, Inc. (1997) Summary page 1.
- K032163: Duracon Total Knee System, Howmedica Osteonics Corp. (2003) Summary page 1.

## 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 coatings 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/K061433
Methodology: https://510kreport.com/methodology