# K892800: MG II Porous Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Aug 3, 1989 after 108 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: 70 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 4 cite it directly.
0 of 13 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
- K050723: MG II Total Knee System Stemmed Tibial Baseplate Components (2005), 6 descendants of its own
- K173057: Zimmer Knee Joint Replacement Prostheses MR Labeling (2018), 5 descendants of its own
- K133737: Zimmer (R)  Persona the Personalized Kee System 14X +30MM Tapered Stem Extension (2014), 5 descendants of its own
- K181947: Persona Revision Knee System (2018), 4 descendants of its own
- K120038: A200 Knee System (2013), 2 descendants of its own

## Recalls of this device
- Jan 11, 2016 · Class II · Z-1143-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Jan 11, 2016 · Class II · Z-1132-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Jan 11, 2016 · Class II · Z-1124-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Oct 11, 2013 · Class II · Z-1037-2014: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packag
- Oct 11, 2013 · Class II · Z-1021-2014: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packag
- Feb 24, 2012 · Not classified · Z-1564-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1585-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1593-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1588-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1577-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1596-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1582-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1598-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1600-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1566-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1552-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1608-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1603-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1549-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1561-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1610-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1605-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1563-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1594-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1555-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1601-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1570-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1583-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1568-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1591-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1587-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1559-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1574-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1556-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1548-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1571-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1569-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1554-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1609-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1604-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1589-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1606-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1578-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1599-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1557-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1579-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1558-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1597-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1590-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a
- Feb 24, 2012 · Not classified · Z-1547-2012: Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components a

Source page: https://510kreport.com/device/K892800
Methodology: https://510kreport.com/methodology