# K113550: Vanguard Complete Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Feb 29, 2012 after 90 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: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K810258 (1981). 40 ancestors in all.
46 later devices descend from it; 18 cite it directly.
0 of 87 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.
- K041046: Maxim Accel (Vanguard) PS+ Bearings, Biomet, Inc. (2004) Summary page 1.
- K050222: Vanguard Anterior Stabilized Tibial Bearings, Biomet, Inc. (2005) Summary page 1.
- K060303: Vanguard PS Open Box Porous Femoral Components, Biomet Manufacturing Corp (2006) Summary page 1.
- K061340: 23 MM Single-Peg Patella Component, Biomet Manufacturing, Inc. (2006) Summary page 1.
- K080528: E-Poly Tibial Bearings, Biomet Orthopedics, Inc. (2008) Summary page 1.

## Most influential descendants
- 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
- K122160: Vanguard XP Knee System (2013), 6 descendants of its own

## Recalls of this device
- Dec 29, 2022 · Class II · Z-1042-2023: Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
- Dec 29, 2022 · Class II · Z-1043-2023: Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
- Oct 22, 2018 · Class II · Z-0495-2019: Label on the outer carton or the patient labels does not match label on the inner sterile packaging
- Oct 22, 2018 · Class II · Z-0496-2019: Label on the outer carton or the patient labels does not match label on the inner sterile packaging
- May 24, 2018 · Class II · Z-2289-2018: Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of surger
- May 11, 2018 · Class II · Z-2183-2018: The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.
- Oct 3, 2017 · Class II · Z-1011-2018: The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur.

## 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 total joint replacement procedure.

Source page: https://510kreport.com/device/K113550
Methodology: https://510kreport.com/methodology