# K153657: Vanguard XP Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: May 10, 2016 after 141 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K810258 (1981). 57 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141407: Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral Trial, Biomet, Inc. (2014) Summary page 4.
- K132873: Vanguard XP Knee System, Biomet, Inc. (2013) Summary page 4.
- K122160: Vanguard XP Knee System, Biomet Manufacturing Corp (2013) Summary page 4.
- K113550: Vanguard Complete Knee System, Biomet Manufacturing Corp (2012) Summary page 4.
- K904448: Townley Total Knee (TTK), Biopro, Inc. (1991) Summary page 4.

## Most influential descendants
- K190068: Vanguard XP Knee System (2019), 0 descendants of its own

## Recalls of this device
- Aug 15, 2019 · Class II · Z-2527-2019: The locking bar not fully engaging

## 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. Regenerex components* are intended only for uncemented biologic fixation application. *Where Available

Source page: https://510kreport.com/device/K153657
Methodology: https://510kreport.com/methodology