# K181569: BKS Revision Sleeves System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corporation
- Decided: Oct 12, 2018 after 120 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 5 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K031201: Ortho Development Balanced Knee Modular Tibial System, Ortho Development Corp. (2003). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K060569: Balanced Knee System Modular Revision Knee System, Ortho Development Corp. (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K103837: Balanced Knee System Revision Offset Tibia, Ortho Development (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K160700: ATTUNE Revision Knee System, Depuy (Ireland) (2016). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K140883: Vanguard 360 Osseoti Tibial Sleeve Augment, Biomet, Inc. (2014). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K242984: BKS Revision System (2024), 0 descendants of its own

## 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 or stem extensions. The BKS Revision is indicated for cemented application only. The porous-coated metaphyseal sleeves are intended for cemented and uncemented biological fixation application.

Source page: https://510kreport.com/device/K181569
Methodology: https://510kreport.com/methodology