# K142933: Biomet Tibial trays

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Dec 23, 2014 after 75 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K915132 (1992). 19 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915132: MCK Maximum Congruent Knee) Knee System, Biomet, Inc. (1992) Summary page 4.
- K010212: Offset Tibial Tray, Biomet, Inc. (2001) Summary page 4.
- 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 4.

## Most influential descendants
- K171054: Biomet Knee Joint Replacement Prostheses (2017), 5 descendants of its own
- 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

## Recalls of this device
- 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
- Dec 15, 2016 · Class II · Z-1219-2017: Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions
- Apr 16, 2015 · Class III · Z-1756-2015: Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.

## Indications for use
Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. Correction of varus, valgus, or posttraumatic deformity. 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.

Source page: https://510kreport.com/device/K142933
Methodology: https://510kreport.com/methodology