# K210695: CPM Medical Consultants Tibial Revision Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Cpm Medical Consultants, LLC
- Decided: Aug 16, 2021 after 161 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 K915132 (1992). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 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 3.
- K150783: Progressive Orthopaedic Total Knee System, The Progressive Orthopaedic Company, LLC (2015) Summary page 3.
- K082424: United U2 Total Knee System, United Orthopedic Corp. (2008) Summary page 4.
- K122183: Augment and Screw, Psa Type, United Orthopedic Corp. (2013) Summary page 4.

## Indications for use
The CPM Medical Consultants Tibial Revision Knee System 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 device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require constrained stabilization for tibiofemoral joint due to soft tissue in-balance. The tibial augments are to be attached to their respective components with a fixation screw or screws. The CPM Medical Consultants Tibial Revision Knee System 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 CPM Medical Consultants Tibial Revision Knee System is designed for cemented use only. The CPM Medical Consultants Tibial Revision Knee System is to be used in conjunction with the Progressive Orthopaedic Company Total Knee System cleared via K142649 & K150783. See below for a compatibility chart between systems.

Source page: https://510kreport.com/device/K210695
Methodology: https://510kreport.com/methodology