# K242984: BKS Revision System

- Pathway: 510(k) (Special)
- Applicant: Ortho Development Corp.
- Decided: Oct 25, 2024 after 29 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: 1 generation back to K181569 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181569: BKS Revision Sleeves System, Ortho Development Corporation (2018) Summary page 5.

## Indications for use
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, BKS TriMax, and BKS Revision are intended for total knee arthroplasty procedures. The BKS is indicated in the salvage of previously failed surgical attempts where bone loss does not require the use of augments or stem extensions and where collateral ligaments may be relied upon for medial/lateral (M/L) stability. BKS TriMax is intended in the salvage of previously failed surgical attempts where bone loss does not require the use of augments or stem extensions, where collateral ligaments may be relied upon for medial/lateral stability, where postoperative flexion up to 150° may be desirable, and the patient meets all indications/contraindications requirements. The BKS Revision system is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves or stem extensions. The BKS Revision system is indicated for cemented use only. The porous-coated metaphyseal sleeves are intended for cemented and uncemented applications. The BKS Revision CK Tibial Insert is indicated for use with the BKS Revision Modular femoral and Modular, Offset, or Sleeve tibial components where collateral ligaments may not be relied upon for medial/lateral (M/L) stability.

Source page: https://510kreport.com/device/K242984
Methodology: https://510kreport.com/methodology