# K080361: Regenerex Tibial Components

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Apr 21, 2008 after 70 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: 4 generations back to K982302 (1998). 24 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053505: Regenerex Ultra Porous Construct-Femoral and Tibial Knee Augments, Biomet Manufacturing, Inc. (2006) Summary page 1.
- 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 1.
- K031462: The Nexgen Knee System Uncemented Components, Implex Corp. (2003) Summary page 1.
- K912245: Agc Revision Knee Prothesis, Biomet, Inc. (1991) Summary page 1.
- K874547: Kirschner Perform Total Knee System Porous Coated, Kirschner Medical Corp. (1987) Summary page 1.

## Most influential descendants
- K101994: Apex Knee Modular  Tibia System (2010), 6 descendants of its own
- K171054: Biomet Knee Joint Replacement Prostheses (2017), 5 descendants of its own
- K131472: Apex Knee Modular Tibia System (2013), 5 descendants of its own
- K181947: Persona Revision Knee System (2018), 4 descendants of its own
- K153437: Apex Revision Knee System (2015), 4 descendants of its own

## Recalls of this device
- Sep 4, 2020 · Class II · Z-0081-2021: Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized

## Indications for use
The indications for the RegenerexTM Tibial Components include: 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 joint replacement procedure. These devices are single-use implants intended for cemented or uncemented applications.

Source page: https://510kreport.com/device/K080361
Methodology: https://510kreport.com/methodology