# K072336: Regenerex Porous Titanium Sleeve Augments

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Nov 5, 2007 after 77 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K982302 (1998). 13 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 18 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.
- K053340: Trabecular Metal Tibial and Femoral Cone Augments, Zimmer Trabecular (2006) Summary page 1.

## Most influential descendants
- K233507: EVOLUTION® Tibial Cones (2024), 0 descendants of its own
- K170149: 3DMetal Tibial Cones (2017), 0 descendants of its own
- K140883: Vanguard 360 Osseoti Tibial Sleeve Augment (2014), 0 descendants of its own
- K100370: Symmetric Total Knee Aguments (2011), 0 descendants of its own

## Indications for use
The Regenerex TM Porous Titanium Sleeve Augments (Femoral and Tibial Sleeve Augments) are indicated for use with the following cemented systems: the Vanguard TM , Ascent Tm, and Maxim® knee systems, as well as the Biomet® Tibial Augmentation Components, Stemmed Tibial Components, Offset Tibial Trays and Offset Tibial Tray Adaptors. The Regenerex TM Porous Titanium Sleeve Augments are indicated for use with following uncemented system: the Vanguard TM Non-Cemented Porous Coated Knee Components. Specific indications are as follows: 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 are single use implants. Cemented and uncemented applications. The RegenereX'TM Porous Titanium Sleeve Augments (Femoral and Tibial Sleeve Augments) are indicated for use with the OSS™ system. Specific indications are as follows: 1. Painful and disabled knee joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis. 2. Correction of varus, valgus, or posttraumnatic deformity. 3. Correction or revision of unsuccessful osteotomny, arthrodesis, or previous joint replacement. 4. Ligament deficiencies. 5. Tumor resection. 6. Trauma. These are single use implants. Cemented applications only.

Source page: https://510kreport.com/device/K072336
Methodology: https://510kreport.com/methodology