# K991581: Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing Femoral and Articular Surface CO

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jul 30, 1999 after 84 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: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
348 later devices descend from it; 19 cite it directly.
0 of 349 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® Complete Knee Solution Legacy® LPS Knee: named in the summary without a submission number

## 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-1043-2018: 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-1044-2018: 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-1045-2018: 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-0832-2016: LDPE bag containing the implant adheres to the highly polished implant surface.
- Jan 11, 2016 · Class II · Z-1152-2016: 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-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 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
This device is intended 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. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. The LPS-Flex Fixed Bearing Knee provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The LPS-Flex femoral, when used with LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees. This device is intended for cemented use only.

Source page: https://510kreport.com/device/K991581
Methodology: https://510kreport.com/methodology