# K170534: Prolixus Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Otis Biotech Co., Ltd.
- Decided: Nov 9, 2017 after 259 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K933785 (1995). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863668: Omnifit (TM) Total Knee Prosthesis System, Osteonics Corp. (1986) Summary page 4.
- K032163: Duracon Total Knee System, Howmedica Osteonics Corp. (2003) Summary page 4.
- K040267: Triathlon Cruciate Retaining (CR) Total Knee, Howmedica Osteonics Corp. (2004) Summary page 4.
- K933785: Next Generation Knee System, Zimmer, Inc. (1995) Summary page 5.
- K023211: Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components, Zimmer, Inc. (2002) Summary page 5.

## Most influential descendants
- K231975: PNK Total Knee System (2023), 0 descendants of its own
- K191192: SurgTech GENOLL Total Knee System (2019), 0 descendants of its own

## Indications for use
This device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature 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. This device system is designed for cement use only.

Source page: https://510kreport.com/device/K170534
Methodology: https://510kreport.com/methodology