# K140883: Vanguard 360 Osseoti Tibial Sleeve Augment

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jul 30, 2014 after 114 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: 5 generations back to K982302 (1998). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093293: Vanguard 360 Revision Knee System, Biomet, Inc. (2010) Summary page 1.
- K121149: Vanguard SSK 360 Revision Knee System, Biomet Manufacturing Corp (2012) Summary page 1.
- K072336: Regenerex Porous Titanium Sleeve Augments, Biomet Manufacturing Corp (2007) Summary page 1.
- K102896: Trabecular Metal Tibial Cone Augments, Zimmer Trabecular Metal Technology (2010) Summary page 1.

## 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. 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) femoral components, tibial tray components and all polyethylene patellar components are indicated for cemented application only. Regenerex and OsseoTi components are intended only for uncemented biologic fixation application. The Vanguard DA 360 components are not intended for use with the Vanguard PS Open Box Porous Femoral components. The Vanguard DA 360 components are not approved for sale in the United States.

Source page: https://510kreport.com/device/K140883
Methodology: https://510kreport.com/methodology