# K102580: Vanguard Removable Molded Poly Tibia

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Mar 3, 2011 after 176 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K915132 (1992). 6 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060525: Vanguard Removable Molded Poly Tibia, Biomet Manufacturing Corp (2006) Summary page 1.
- K915132: MCK Maximum Congruent Knee) Knee System, Biomet, Inc. (1992) Summary page 1.

## Most influential descendants
- K122160: Vanguard XP Knee System (2013), 6 descendants of its own
- K132873: Vanguard XP Knee System (2013), 3 descendants of its own
- K141407: Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral Trial (2014), 2 descendants of its own
- K153657: Vanguard XP Knee System (2016), 1 descendant of its own
- K142814: Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial (2015), 1 descendant of its own

## Indications for use
The Vanguard® Cruciate Molded Poly Tibia is intended for: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis traumatic arthritis where one or more compartments are involved; 2. Failure of a previous joint replacement procedure 3. Correction of varus, valgus, or post traumatic deformity; 4. Correction or revision of unsuccessful osteotomy or arthrodesis. The device is a single use implant intended for use with bone cement.

Source page: https://510kreport.com/device/K102580
Methodology: https://510kreport.com/methodology