# K121149: Vanguard SSK 360 Revision Knee System

- Pathway: 510(k) (Special)
- Applicant: Biomet Manufacturing Corp
- Decided: May 16, 2012 after 30 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: 4 generations back to K915132 (1992). 6 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093293: Vanguard 360 Revision Knee System, Biomet, Inc. (2010) Summary page 1.

## Most influential descendants
- K171054: Biomet Knee Joint Replacement Prostheses (2017), 5 descendants of its own
- K181947: Persona Revision Knee System (2018), 4 descendants of its own
- K191625: Persona Revision Knee System (2019), 1 descendant of its own
- K243724: Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) (2025), 0 descendants of its own
- K210829: Persona Revision Knee System Femoral Metaphyseal Cones (2021), 0 descendants of its own

## 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. The Regenerexm femoral augments are indicated for use with the Vanguard" Total Knee System. The Regenerex tibial augments are indicated for use with standard and offset Biomet® Tibial Trays. Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (InterlokTM) devices and all-polyethylene patellar components are indicated for cemented application only. Regenerex TM components are intended only for uncemented biologic fixation application.

Source page: https://510kreport.com/device/K121149
Methodology: https://510kreport.com/methodology