# K112285: Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / RLP, Uncoated; Tibial Insert / Baseplate...

- Pathway: 510(k) (Traditional)
- Applicant: Tgm Medical, Inc.
- Decided: Nov 4, 2011 after 87 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: 6 generations back to K933785 (1995). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932837: Consensus Knee System - Primary Knee, U.S. Medical Products, Inc. (1994) Summary page 2.
- K945589: Consensus (TM) Knee Cobalt Chrome Nonporous Stemmed Tibial Baseplate, U.S. Medical Products, Inc. (1995) Summary page 2.
- K954818: Consensus Posterior Stabilized Knee, U.S. Medical Products, Inc. (1996) Summary page 2.
- K001456: Consensus Knee System, Hayes Medical, Inc. (2000) Summary page 2.
- K110950: Consensus Knee System, Consensus Orthopedics, Inc. (2011) Summary page 2.

## Most influential descendants
- K130084: Milestone Revision Knee System (MRKS) - Femoral Component, Tibial Baseplate, Tibial Insert, Stems, Femoral & Tibial Augm (2013), 0 descendants of its own

## Indications for use
The MILESTONE Knee System Primary Knee is designed as a system and is not intended for substitution of components from other systems. A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis. B. Failed osteotomy or unicompartmental replacements. C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists. All MILESTONE Knee components are intended for cemented use only

Source page: https://510kreport.com/device/K112285
Methodology: https://510kreport.com/methodology