# K171054: Biomet Knee Joint Replacement Prostheses

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jul 28, 2017 after 109 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: 4 (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). 65 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912245: Agc Revision Knee Prothesis, Biomet, Inc. (1991) Summary page 5.
- K915132: MCK Maximum Congruent Knee) Knee System, Biomet, Inc. (1992) Summary page 5.
- K921182: Ultra High Molecular Weight Polyethylene Component, Biomet, Inc. (1993) Summary page 5.
- K960856: Konstruct Patellar Component, Biomet, Inc. (1996) Summary page 5.
- K993159: Maxim Knee System, Biomet, Inc. (1999) Summary page 5.
- K010212: Offset Tibial Tray, Biomet, Inc. (2001) Summary page 5.
- K033489: Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim Accel Knee System Also Known, Biomet, Inc. (2004) Summary page 5.
- K040770: Vanguard Patella Components, Biomet Manufacturing, Inc. (2004) Summary page 5.
- K042757: Vanguard SSK Knee System, Biomet, Inc. (2005) Summary page 5.
- K060525: Vanguard Removable Molded Poly Tibia, Biomet Manufacturing Corp (2006) Summary page 5.
- K080204: Vanguard Knee System Titanium Femoral Components, Biomet, Inc. (2008) Summary page 5.
- K080361: Regenerex Tibial Components, Biomet, Inc. (2008) Summary page 5.
- K083782: Regenerex Patella Components, Biomet Manufacturing Corp (2009) Summary page 5.
- K102125: Patient-Specific Vanguard Femoral Componets, Biomet, Inc. (2011) Summary page 5.
- K110362: Vanguard Asymmetrical Patellar Component, Biomet Manufacturing Corp (2011) Summary page 5.
- K113550: Vanguard Complete Knee System, Biomet Manufacturing Corp (2012) Summary page 5.
- K121149: Vanguard SSK 360 Revision Knee System, Biomet Manufacturing Corp (2012) Summary page 5.
- K140902: E1 Series a Patellae, Standard 3-Peg, E1 Series a Patellae, Thin 3-Peg, E1 Series Patellae, Asymmetrical, 3-Peg, Biomet, Inc. (2014) Summary page 5.
- K142933: Biomet Tibial trays, Biomet, Inc. (2014) Summary page 5.

## Most influential descendants
- 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
- K210551: Persona Revision Knee System (2021), 0 descendants of its own

## Recalls of this device
- Dec 21, 2018 · Class II · Z-0938-2019: Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.
- May 24, 2018 · Class II · Z-2289-2018: Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of surger
- May 18, 2018 · Class II · Z-2177-2018: One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component a
- May 11, 2018 · Class II · Z-2183-2018: The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.

## Indications for use
1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, and/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 joint replacement procedure. The Regenerex 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 (Interlok) devices and all-polyethylene patellar components are indicated for cemented application only. Regenerex components are intended only for uncemented biologic fixation application. The tibial bearings are intended for use with Biomet cemented or uncemented tibial trays. All-polyethylene patellar components are indicated for cemented use only.

Source page: https://510kreport.com/device/K171054
Methodology: https://510kreport.com/methodology