# K122160: Vanguard XP Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Mar 20, 2013 after 243 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: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K810258 (1981). 54 ancestors in all.
6 later devices descend from it; 6 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113550: Vanguard Complete Knee System, Biomet Manufacturing Corp (2012) Summary page 1.
- K102580: Vanguard Removable Molded Poly Tibia, Biomet Manufacturing Corp (2011) Summary page 1.
- K080528: E-Poly Tibial Bearings, Biomet Orthopedics, Inc. (2008) Summary page 1.
- K904448: Townley Total Knee (TTK), Biopro, Inc. (1991) Summary page 1.
- K833363: Cloutier II Fiber Metal Total Knee, Zimmer, Inc. (1984) Summary page 1.
- K031061: Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components, Zimmer, Inc. (2003) Summary page 1.
- K050222: Vanguard Anterior Stabilized Tibial Bearings, Biomet, Inc. (2005) Summary page 1.
- K961021: Kirschner Knee Modified, Biomet, Inc. (1997) Summary page 2.
- K921182: Ultra High Molecular Weight Polyethylene Component, Biomet, Inc. (1993) Summary page 2.
- K993159: Maxim Knee System, Biomet, Inc. (1999) Summary page 2.

## Most influential descendants
- K132873: Vanguard XP Knee System (2013), 3 descendants of its own
- K141407: Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral Trial (2014), 2 descendants of its own
- K153657: Vanguard XP Knee System (2016), 1 descendant of its own
- K190068: Vanguard XP Knee System (2019), 0 descendants of its own
- K143635: KINETIS Total Knee System (2015), 0 descendants of its own

## Recalls of this device
- Aug 15, 2019 · Class II · Z-2503-2019: The locking bar not fully engaging
- Aug 15, 2019 · Class II · Z-2528-2019: The locking bar not fully engaging
- Aug 15, 2019 · Class II · Z-2537-2019: The locking bar not fully engaging
- Aug 15, 2019 · Class II · Z-2533-2019: The locking bar not fully engaging
- Aug 15, 2019 · Class II · Z-2532-2019: The locking bar not fully engaging
- Aug 15, 2019 · Class II · Z-2535-2019: The locking bar not fully engaging
- Aug 15, 2019 · Class II · Z-2515-2019: The locking bar not fully engaging
- Aug 15, 2019 · Class II · Z-2530-2019: The locking bar not fully engaging
- Aug 15, 2019 · Class II · Z-2536-2019: The locking bar not fully engaging
- Aug 15, 2019 · Class II · Z-2531-2019: The locking bar not fully engaging
- Aug 15, 2019 · Class II · Z-2534-2019: The locking bar not fully engaging
- Aug 15, 2019 · Class II · Z-2529-2019: 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®) devices and all polyethylene patellar components are indicated for cemented application only. Regenerex components are intended only for uncemented biologic fixation application.

Source page: https://510kreport.com/device/K122160
Methodology: https://510kreport.com/methodology