# K130084: Milestone Revision Knee System (MRKS) - Femoral Component, Tibial Baseplate, Tibial Insert, Stems, Femoral & Tibial Augm

- Pathway: 510(k) (Traditional)
- Applicant: Tgm Medical, Inc.
- Decided: May 3, 2013 after 109 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: 7 generations back to K933785 (1995). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953443: Consensus PCL Subsituting Tibial Insert, U.S. Medical Products, Inc. (1996) Summary page 2.
- K100542: Consensus Revision Knee System, Consensus Orthopedics, Inc. (2010) Summary page 2.
- K112285: Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / RLP, Uncoated; Tibial Insert / Baseplate..., Tgm Medical, Inc. (2011) Summary page 3.

## Indications for use
A. Primary intervention of rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle. B. Post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy). C. Failed osteotomy or unicompartmental replacements. D. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists. E. The salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. F. Moderate valgus, varus, or flexion deformities. All MRKS femoral components and tibial baseplates are intended for CEMENTED USE ONLY. All MRKS stems are intended for UNCEMENTED USE.

Source page: https://510kreport.com/device/K130084
Methodology: https://510kreport.com/methodology