# K190068: Vanguard XP Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jun 4, 2019 after 140 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: 11 generations back to K810258 (1981). 109 ancestors in all.
No later device cites it as a predicate yet.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122160: Vanguard XP Knee System, Biomet Manufacturing Corp (2013) Summary page 4.
- K132873: Vanguard XP Knee System, Biomet, Inc. (2013) Summary page 4.
- K141407: Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral Trial, Biomet, Inc. (2014) Summary page 4.
- K153657: Vanguard XP Knee System, Biomet, Inc. (2016) Summary page 5.
- K121771: Zimmer Persona the Personalized Knee System, Zimmer, Inc. (2012) Summary page 5.
- K150090: Zimmer Persona Personalized Knee System, Zimmer, Inc. (2015) Summary page 5.

## Indications for use
1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or 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. Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok) femoral components, tibial tray components and all polyethylene patellar components are indicated for cemented application only.

Source page: https://510kreport.com/device/K190068
Methodology: https://510kreport.com/methodology