# K183583: Vanguard Complete Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: May 10, 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). 97 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 99 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 4.
- K041046: Maxim Accel (Vanguard) PS+ Bearings, Biomet, Inc. (2004) Summary page 4.
- K050222: Vanguard Anterior Stabilized Tibial Bearings, Biomet, Inc. (2005) Summary page 4.
- K080528: E-Poly Tibial Bearings, Biomet Orthopedics, Inc. (2008) Summary page 4.
- K113550: Vanguard Complete Knee System, Biomet Manufacturing Corp (2012) 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.

## Most influential descendants
- K253961: SK Knee System (2026), 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. Femoral components and tibial tray components with porous coatings are indicated for cemented and un-cemented biological fixation application. Non-coated (interlok®) devices and all polyethylene patellar components are indicated for cemented application only.

Source page: https://510kreport.com/device/K183583
Methodology: https://510kreport.com/methodology