# K182085: Balanced Knee Revision System Trabecular Tibial Cone Augments

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corporation
- Decided: Oct 31, 2018 after 90 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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053340: Trabecular Metal Tibial and Femoral Cone Augments, Zimmer Trabecular (2006) Summary page 4.
- K102896: Trabecular Metal Tibial Cone Augments, Zimmer Trabecular Metal Technology (2010) Summary page 4.

## Indications for use
These devices are intended for use in total knee arthroplasty procedures for the following conditions: 1. Loss of joint configuration and joint function. 2. Osteoarthritis of the knee joint. 3. Rheumatoid arthritis of the knee joint. 4. Post-traumatic arthritis of the knee joint. 5. Valgus, varus, or flexion deformities of the knee joint. 6. Revision procedures where other treatments or devices have failed. The BKS Revision is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves, cones or stem extensions. The BKS Revision System Trabecular Tibial Cone Augments are for cemented or cementless use.

Source page: https://510kreport.com/device/K182085
Methodology: https://510kreport.com/methodology