# K060525: Vanguard Removable Molded Poly Tibia

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: May 25, 2006 after 87 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: 3 (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). 5 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991753: Maxim Removable Molded Poly Tibia, Biomet, Inc. (1999) Summary page 1.
- K984623: Maxim Removable Molded Poly Tibia, Biomet, Inc. (1999) Summary page 1.
- K023546: Maxim Accel Knee System, Biomet, Inc. (2003) Summary page 1.

## Most influential descendants
- K102580: Vanguard Removable Molded Poly Tibia (2011), 9 descendants of its own
- K122160: Vanguard XP Knee System (2013), 6 descendants of its own
- K171054: Biomet Knee Joint Replacement Prostheses (2017), 5 descendants of its own
- K181947: Persona Revision Knee System (2018), 4 descendants of its own
- K132873: Vanguard XP Knee System (2013), 3 descendants of its own

## Recalls of this device
- Apr 17, 2020 · Class II · Z-2152-2020: Potential presence of elevated endotoxin levels that exceed the specification limit
- Apr 17, 2020 · Class II · Z-2151-2020: Potential presence of elevated endotoxin levels that exceed the specification limit
- Feb 17, 2017 · Class II · Z-1861-2017: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

## 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. The device is a single use implant intended for use with bone cement.

Source page: https://510kreport.com/device/K060525
Methodology: https://510kreport.com/methodology