# K053505: Regenerex Ultra Porous Construct-Femoral and Tibial Knee Augments

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing, Inc.
- Decided: Aug 14, 2006 after 241 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K982302 (1998). 7 ancestors in all.
19 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023546: Maxim Accel Knee System, Biomet, Inc. (2003) Summary page 1.
- K915132: MCK Maximum Congruent Knee) Knee System, Biomet, Inc. (1992) Summary page 1.
- K040487: Trabecular Metal Knee System Augments, Implex Corp. (2004) Summary page 1.
- K024161: Nexgen Complete Knee Solution - Trabecular Metal Augments, Implex Corp. (2003) Summary page 1.
- K002757: Oncology Salvage System, Biomet, Inc. (2000) Summary page 1.

## Most influential descendants
- K080361: Regenerex Tibial Components (2008), 13 descendants of its own
- 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

## Indications for use
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. Cemented and uncemented applications The Regenerex T M femoral augments are indicated for use with the VanguardTM Total Knee System. The Regenerex TM tibial augments are indicated for use with standard and offset Biomet® Tibial Trays. 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement 4. Ligament deficiencies 5. Tumor Resection 6. Revision of previously failed total joint arthroplasty 7. Trauma These are single use implants These devices are for cemented use only

Source page: https://510kreport.com/device/K053505
Methodology: https://510kreport.com/methodology