# K933785: Next Generation Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jan 30, 1995 after 544 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: 83 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
328 later devices descend from it; 15 cite it directly.
0 of 329 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
- K023211: Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components (2002), 293 descendants of its own
- K060370: Nexgen Knee Gender Solutions Female (GSF) Femoral Components (2006), 197 descendants of its own
- K031061: Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components (2003), 193 descendants of its own
- K070214: Gender Solutions Natural-Knee Flex System (2007), 123 descendants of its own
- K070695: Zimmer Patellofemoral Joint Prosthesis (2007), 122 descendants of its own

## Recalls of this device
- Nov 29, 2017 · Class II · Z-1039-2018: 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
- Nov 29, 2017 · Class II · Z-1041-2018: 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
- Nov 29, 2017 · Class II · Z-1040-2018: 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
- Nov 29, 2017 · Class II · Z-1038-2018: 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
- Nov 29, 2017 · Class II · Z-1042-2018: 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
- Apr 28, 2017 · Class II · Z-2115-2017: Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labe
- Jan 11, 2016 · Class II · Z-1147-2016: 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-1151-2016: 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-0835-2016: LDPE bag containing the implant adheres to the highly polished implant surface.
- Jan 11, 2016 · Class II · Z-1159-2016: 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.
- Dec 3, 2015 · Class II · Z-0590-2016: A product complaint was received stating that a carton labeled as a Precoat Stemmed Tibia Size 3 was opened for use and the contents were a non-augmented Stemmed Tibia Plate size 3.
- Dec 2, 2015 · Class II · Z-0449-2016: Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on the inner package of P/N:00-5980-037-01 unit from lot #62460264
- Jul 22, 2014 · Class II · Z-2552-2014: Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples f
- Oct 31, 2013 · Class II · Z-0480-2014: Two complaints were received in which it was reported that the stem would not lock into the tibia. Evaluation of the returned device found that the stemmed portion of the tibial plate would not hold t
- Oct 11, 2013 · Class II · Z-1023-2014: 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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
- 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-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-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-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-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-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-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-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-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

Source page: https://510kreport.com/device/K933785
Methodology: https://510kreport.com/methodology