# K872379: Insall/Burstein* II Modular Total Knee

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Oct 28, 1987 after 131 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: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
55 later devices descend from it; 5 cite it directly.
0 of 56 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
- 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
- K153310: Klassic Knee System (2015), 24 descendants of its own
- K153075: Klassic Knee System (2015), 24 descendants of its own

## Recalls of this device
- Dec 6, 2022 · Class II · Z-0468-2023: Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates w
- Dec 6, 2022 · Class II · Z-0471-2023: Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates w
- Dec 6, 2022 · Class II · Z-0466-2023: Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates w
- Dec 6, 2022 · Class II · Z-0467-2023: Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates w
- Dec 6, 2022 · Class II · Z-0469-2023: Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates w
- Dec 6, 2022 · Class II · Z-0470-2023: Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates w
- Jan 11, 2016 · Class II · Z-1133-2016: 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-1149-2016: 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-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
- 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
- Sep 21, 2012 · Class II · Z-0437-2013: Zimmer is initiating a lot specific recall of the NexGen Stemmed Nonaugmentable Tibial Component due to the devices being processed through a manufacturing cleaning operation that was operating outsid

Source page: https://510kreport.com/device/K872379
Methodology: https://510kreport.com/methodology