# K093293: Vanguard 360 Revision Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Oct 22, 2010 after 366 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: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K915132 (1992). 5 ancestors in all.
21 later devices descend from it; 6 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042757: Vanguard SSK Knee System, Biomet, Inc. (2005) Summary page 1.
- K010212: Offset Tibial Tray, Biomet, Inc. (2001) Summary page 1.
- K915132: MCK Maximum Congruent Knee) Knee System, Biomet, Inc. (1992) Summary page 1.

## Most influential descendants
- K122183: Augment and Screw, Psa Type (2013), 10 descendants of its own
- K121149: Vanguard SSK 360 Revision Knee System (2012), 7 descendants of its own
- K171054: Biomet Knee Joint Replacement Prostheses (2017), 5 descendants of its own
- K131864: U2 Tibial Baseplate- Cma Type, Tibial Insert and Augment (2014), 5 descendants of its own
- K181947: Persona Revision Knee System (2018), 4 descendants of its own

## Recalls of this device
- Dec 1, 2020 · Class II · Z-0723-2021: Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure
- Aug 2, 2018 · Class II · Z-3249-2018: The implant only has one bolt in the sterile package but it should have had two.
- Aug 2, 2018 · Class II · Z-3250-2018: The implant only has one bolt in the sterile package but it should have had two.
- Aug 8, 2016 · Class II · Z-0003-2017: The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolts included in the Vanguard 360 Revision Knee System was larger than allowable per the process specifica
- Jul 1, 2014 · Class II · Z-2242-2014: The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component.

## Indications for use
The indications for the Vanguard 360 Revision Knee System are as follows: 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. These devices are single-use implants intended for cemented use only.

Source page: https://510kreport.com/device/K093293
Methodology: https://510kreport.com/methodology