# K020214: Medial Rotation Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Engineering Consulting Services, Inc.
- Decided: Feb 26, 2002 after 35 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: 1 generation back to K830726 (1983). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K830726: Mark I & II Total Knee Replace. Sys, Advanced Biosearch Assn. (1983) Summary page 1.
- K853730: Freeman-Samuelson Mark II Press-Fit Total Knee Rep, Protek, Inc. (1986) Summary page 1.
- K943025: Freeman/Samuelson Total Knee System, Biomet, Inc. (1996) Summary page 1.
- K972770: Advance Ultra-Congruent Tibial Insert, Wrightmedicaltechnologyinc (1997) Summary page 1.
- K991052: FS 1000 Knee System, Renaissance Instruments, LLC (1999) Summary page 1.

## Most influential descendants
- K140222: Saiph Knee System (2014), 0 descendants of its own

## Indications for use
The Medial Rotation Knee™ System is intended for single-use ‘cemented’ implantation for use in a total knee arthroplasty surgery for the reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: ¢ Non-inflammatory degenerative joint disease resulting from osteoarthritis, traumatic arthritis, or avascular necrosis; Inflammatory degenerative joint disease including rheumatoid arthritis; Correction of varus, valgus, or post traumatic deformity; Correction or revision of unsuccessful osteotomy or arthrodesis; Revision procedures where other treatments or devices have failed; Treatment of fractures that are unmanageable using other techniques;

Source page: https://510kreport.com/device/K020214
Methodology: https://510kreport.com/methodology