# K183344: The Progressive Orthopaedic Company Total Knee System II

- Pathway: 510(k) (Traditional)
- Applicant: The Progressive Orthopaedic Company, LLC
- Decided: Mar 18, 2019 after 105 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: 5 generations back to K021657 (2002). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142649: Progressive Orthopedic Total Knee System, The Progressive Orthopaedic Company, LLC (2015) Summary page 4.
- K150783: Progressive Orthopaedic Total Knee System, The Progressive Orthopaedic Company, LLC (2015) Summary page 4.

## Indications for use
The Progressive Orthopaedic Company Total Knee System II is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. The Progressive Orthopaedic Company Total Knee System II may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. The Progressive Orthopaedic Company Total Knee System II is designed for cemented use only.

Source page: https://510kreport.com/device/K183344
Methodology: https://510kreport.com/methodology