# K043101: Nexgen Complete Knee Solution Mis Tibial Components, Locking Screw and Stem Extensions

- Pathway: 510(k) (Special)
- Applicant: Zimmer, Inc.
- Decided: Mar 7, 2005 after 118 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: 22 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K933785 (1995). 5 ancestors in all.
59 later devices descend from it; 3 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933785: Next Generation Knee System, Zimmer, Inc. (1995) Summary page 1.
- K991581: Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing Femoral and Articular Surface CO, Zimmer, Inc. (1999) Summary page 1.
- K031061: Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components, Zimmer, Inc. (2003) Summary page 1.

## Most influential descendants
- K090988: GMK Total Knee System (2009), 52 descendants of its own
- K102437: GMK Revision Knee System (2010), 34 descendants of its own
- K103170: GMK Revision Knee SC Liners (2011), 28 descendants of its own
- K113571: GMK Resufacing Patella Size 4 (2012), 23 descendants of its own
- K121416: GMK Sphere (2012), 20 descendants of its own

## Recalls of this device
- Jan 11, 2016 · Class II · Z-1148-2016: 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.
- May 19, 2014 · Class II · Z-1935-2014: Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
- May 19, 2014 · Class II · Z-1936-2014: Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
- May 19, 2014 · Class II · Z-1933-2014: Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
- May 19, 2014 · Class II · Z-1931-2014: Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
- May 19, 2014 · Class II · Z-1932-2014: Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
- May 19, 2014 · Class II · Z-1934-2014: Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
- May 19, 2014 · Class II · Z-1938-2014: Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
- May 19, 2014 · Class II · Z-1937-2014: Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
- May 19, 2014 · Class II · Z-1939-2014: Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
- 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
- Apr 26, 2010 · Not classified · Z-2415-2010: The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required addition
- Apr 26, 2010 · Not classified · Z-2414-2010: The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required addition
- Apr 26, 2010 · Not classified · Z-2411-2010: The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required addition
- Apr 26, 2010 · Not classified · Z-2416-2010: The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required addition
- Apr 26, 2010 · Not classified · Z-2413-2010: The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required addition
- Apr 26, 2010 · Not classified · Z-2408-2010: The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required addition
- Apr 26, 2010 · Not classified · Z-2418-2010: The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required addition
- Apr 26, 2010 · Not classified · Z-2417-2010: The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required addition
- Apr 26, 2010 · Not classified · Z-2409-2010: The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required addition
- Apr 26, 2010 · Not classified · Z-2410-2010: The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required addition
- Apr 26, 2010 · Not classified · Z-2412-2010: The firm has received complaints of loosening of the implanted device requiring revision surgery. There have been 114 MDRs filed all reported that the device loosened and the patient required addition

## Indications for use
This device is indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. - Collagen disorders and/or avascular necrosis of the femoral condyle. - Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy - Moderate valgus, varus or flexion deformities. - The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. This device is intended for cemented use only.

Source page: https://510kreport.com/device/K043101
Methodology: https://510kreport.com/methodology