# K894334: Second Generation Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Orthomet, Inc.
- Decided: Oct 6, 1989 after 84 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
No predicates in its family tree.
9 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K113325: Evolution MP Adaptive CS Insert (2011), 7 descendants of its own
- K131679: Evolution MP Adaptive PS Tibial Insert (2013), 6 descendants of its own
- K140735: Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS Inserts (2014), 5 descendants of its own
- K122218: Advance Total Knee System-Patella (2013), 2 descendants of its own
- K243574: Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique (2025), 1 descendant of its own

Source page: https://510kreport.com/device/K894334
Methodology: https://510kreport.com/methodology