# K936159: Natural-Knee II System

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics Orthopedics
- Decided: May 22, 1995 after 515 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: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
161 later devices descend from it; 8 cite it directly.
0 of 162 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
- K113369: Zimmer Persona Knee System (2012), 96 descendants of its own
- K121771: Zimmer Persona the Personalized Knee System (2012), 59 descendants of its own
- K090705: Balanced Knee System Ultracongruent Tibial Insert (2009), 42 descendants of its own
- K112906: Klassic Knee System (2012), 33 descendants of its own
- K140942: Klassic Knee Tibial Stem Extension (2014), 27 descendants of its own

## Recalls of this device
- Nov 29, 2017 · Class II · Z-1033-2018: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed fro
- Jan 11, 2016 · Class II · Z-0839-2016: LDPE bag containing the implant adheres to the highly polished implant surface.
- Feb 25, 2014 · Class II · Z-1262-2014: A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a
- Feb 25, 2014 · Class II · Z-1249-2014: A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a
- Aug 30, 2013 · Class II · Z-0075-2014: The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
- Aug 30, 2013 · Class II · Z-0078-2014: The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.

Source page: https://510kreport.com/device/K936159
Methodology: https://510kreport.com/methodology