# K960279: Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral Components/Articular Surfaces - Pathway: 510(k) (Traditional) - Applicant: Zimmer, Inc. - Decided: Apr 26, 1996 after 98 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: 21 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage No predicates in its family tree. 312 later devices descend from it; 13 cite it directly. 0 of 313 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - None. The FDA summary names its predicate without a number. - (no number) NexGen Posterior Stabilized: named in the summary without a submission number - (no number) Insall/Burstein 11 Posterior Stabilized: named in the summary without a submission number - (no number) NexGen Constrained Condylar Knee: named in the summary without a submission number - (no number) Insall/Burstein 11 Modular Knee System: named in the summary without a submission number - (no number) Insall/Burstein Constrained Condylar Knee: named in the summary without a submission number ## Most influential descendants - K031061: Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components (2003), 193 descendants of its own - K994128: Scorpio Total Stablizer (TS) Total Knee System (2000), 139 descendants of its own - K021313: Search Evolution Total Knee System (2002), 120 descendants of its own - K072160: Nexgen Trabecular Metal Tibial Tray (2007), 108 descendants of its own - K072619: Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF) Porous Femoral Components (2007), 102 descendants of its own ## Recalls of this device - Jan 6, 2025 · Class II · Z-1038-2025: It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope. - Jan 6, 2025 · Class II · Z-1039-2025: It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope. - Nov 29, 2017 · Class II · Z-1035-2018: 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-1036-2018: 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-1034-2018: 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-1037-2018: 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 - Jan 11, 2016 · Class II · Z-0834-2016: LDPE bag containing the implant adheres to the highly polished implant surface. - Jan 11, 2016 · Class II · Z-1146-2016: 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. - Apr 2, 2015 · Class II · Z-1575-2015: The affected lot is being recalled because it was packaged without the locking screw. The locking screw packaged with the augment is used to fix the augment to the femoral component. This has the pote - 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 15, 2010 · Not classified · Z-0528-2011: These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The con - Sep 15, 2010 · Not classified · Z-0529-2011: These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The con - Sep 15, 2010 · Not classified · Z-0532-2011: These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The con - Sep 15, 2010 · Not classified · Z-0533-2011: These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The con - Sep 15, 2010 · Not classified · Z-0534-2011: These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The con - Sep 15, 2010 · Not classified · Z-0535-2011: These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The con - Sep 15, 2010 · Not classified · Z-0530-2011: These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The con - Sep 15, 2010 · Not classified · Z-0531-2011: These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The con - Sep 15, 2010 · Not classified · Z-0536-2011: These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The con - Apr 16, 2010 · Not classified · Z-0609-2011: The impactor may disassemble or detach during use. The detached piece may not be observed intraoperatively and may be left in the surgical site. Complications may include pain, infection, and prolonga ## Indications for use To reduce or relieve pain and restore function and motion to the knee joint. Total knee replacement is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus varus or flexion deformities. Source page: https://510kreport.com/device/K960279 Methodology: https://510kreport.com/methodology