# K102927: Consensus Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Consensus Orthopedics, Inc.
- Decided: Jan 26, 2011 after 114 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- 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 K951987 (1995). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001456: Consensus Knee System, Hayes Medical, Inc. (2000) Summary page 2.
- K983004: Consensus Femoral Component, Porous, Cocr/TI, Hayes Medical, Inc. (1998) Summary page 2.
- K051229: Profix  Flex Cruciate Retaining Articular Insert, Smith & Nephew, Inc. (2005)
- K030623: Smith & Nephew Profix Total Knee System, Smith & Nephew, Inc. (2003) Summary page 2.
- K033489: Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim Accel Knee System Also Known, Biomet, Inc. (2004) Summary page 2.
- K073286: Gender Solutions Natural-Knee Flex System, Zimmer, Inc. (2008) Summary page 2.
- K070214: Gender Solutions Natural-Knee Flex System, Zimmer, Inc. (2007) Summary page 2.

## Indications for use
The CONSENSUS® 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 unicompatmental replacements. C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists. D. The porous coated (CoCr beads with Titanium) femoral and tibial components may be used with or without cement.

Source page: https://510kreport.com/device/K102927
Methodology: https://510kreport.com/methodology